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Birhanu, M., Abegaz, W. E., Schröder, D., Mihret, A., Abebe, T., Jacobsson, S., . . . Unemo, M. (2024). Antimicrobial susceptibility in Neisseria gonorrhoeae and epidemiological data of gonorrhoea patients in five cities across Ethiopia, 2021-22. JAC-antimicrobial resistance, 6(1), Article ID dlae002.
Open this publication in new window or tab >>Antimicrobial susceptibility in Neisseria gonorrhoeae and epidemiological data of gonorrhoea patients in five cities across Ethiopia, 2021-22
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2024 (English)In: JAC-antimicrobial resistance, E-ISSN 2632-1823, Vol. 6, no 1, article id dlae002Article in journal (Refereed) Published
Abstract [en]

INTRODUCTION: Antimicrobial resistance (AMR) in Neisseria gonorrhoeae is a global public health concern and enhanced global gonococcal AMR surveillance is imperative. As in many African countries, regular, representative and quality-assured gonococcal AMR is lacking in Ethiopia. We describe the AMR in gonococcal isolates from five cities across Ethiopia, 2021-22, and patient epidemiological data.

METHODS: Urethral discharge from males and cervical discharge from females were collected from October 2021 to September 2022. Epidemiological data were collected using a questionnaire. MIC determination (ETEST; eight antimicrobials) was performed on gonococcal isolates and EUCAST breakpoints (v13.1) were used.

RESULTS: From 1142 urogenital swab samples, 299 species-identified gonococcal isolates were identified; 78.3% were from males and 21.7% from females. The median age for males and females was 25 and 23 years, respectively. Most isolates (61.2%) were identified in Addis Ababa, followed by Gondar (11.4%), Adama (10.4%), Bahir Dar (10.0%) and Jimma (7.0%). The resistance level to ciprofloxacin, tetracycline and benzylpenicillin was 97.0%, 97.0% and 87.6%, respectively, and 87.6% of isolates were producing β-lactamase. All isolates were susceptible to ceftriaxone, cefixime, azithromycin and spectinomycin. Recommended therapy [ceftriaxone (250 mg) plus azithromycin (1 g)] was used for 84.2% of patients.

CONCLUSIONS: We present the first national quality-assured gonococcal AMR data from Ethiopia. Resistance levels to ciprofloxacin, tetracycline and benzylpenicillin were exceedingly high. However, all isolates were susceptible to ceftriaxone, cefixime, azithromycin and spectinomycin. In Ethiopia, it is essential to strengthen the gonococcal AMR surveillance by including further epidemiological data, more isolates from different cities, and WGS.

Place, publisher, year, edition, pages
Oxford University Press, 2024
National Category
Infectious Medicine
Identifiers
urn:nbn:se:oru:diva-111376 (URN)10.1093/jacamr/dlae002 (DOI)001155688400002 ()38304725 (PubMedID)2-s2.0-85184511888 (Scopus ID)
Funder
Region Örebro County
Note

The present study was supported by Addis Ababa University, College of Health Science (2019) and the Örebro Country Council Research Committee and the Foundation for Medical Research at Örebro University Hospital (2021), Örebro, Sweden.

Available from: 2024-02-05 Created: 2024-02-05 Last updated: 2024-02-20Bibliographically approved
Manjate, A., Andersson, S., Golparian, D., Kenga, D., Langa, J., Passanduca, A., . . . Unemo, M. (2024). Assessment of the performance of a multiplex real-time PCR, AmpliSens Florocenosis/Bacterial Vaginosis-FRT, versus Nugent's criteria in the diagnosis of BV in women in Mozambique. Paper presented at Annual Meeting of the Infectious-Diseases-Society-for-Obstetrics-and-Gynecology (IDSOG), Boston, MA, USA, August 4-6, 2022. Sexually Transmitted Diseases, 51(1S), S433-S434, Article ID P469.
Open this publication in new window or tab >>Assessment of the performance of a multiplex real-time PCR, AmpliSens Florocenosis/Bacterial Vaginosis-FRT, versus Nugent's criteria in the diagnosis of BV in women in Mozambique
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2024 (English)In: Sexually Transmitted Diseases, ISSN 0148-5717, E-ISSN 1537-4521, Vol. 51, no 1S, p. S433-S434, article id P469Article in journal, Meeting abstract (Other academic) Published
Abstract [en]

Background: Bacterial vaginosis (BV) is a common vaginal disorder among women of reproductive age, and BV can be associated with adverse pregnancy outcomes and enhanced acquisition and transmission of STIs/HIV. The present study aimed to determine the prevalence of BV using the Nugent score and sociodemographic factors associated with BV among women in Maputo, Mozambique, and to evaluate the performance of the AmpliSens® Florocenosis/Bacterial vaginosis-FRT PCR kit versus Nugent score for diagnosis of BV.

Material and Methods: Vaginal swabs were collected from 886 non-pregnant symptomatic women during their visit to the Mavalane Health area in Maputo, Mozambique from February 2018 to January 2019. BV was diagnosed by Nugent score. The AmpliSens®Florocenosis/Bacterial vaginosis-FRT PCR kit (InterLabService, Moscow, Russia) was evaluated for BV diagnosis. HIV was detected using Determine HIV1/2 (Alere Medical Co. Ltd, Chiba, Japan) plus Uni-Gold HIV1/2 (Trinity Biotech, Ireland). The chisquare test was used to estimate associations between categorical variables.

Results: The prevalence of BV by PCR, Nugent score, and HIV was 47.2%, 39.1%, and 22.5%, respectively. Of those with BV, 52% were HIV-positive and 48% HIV-negative (p < 0.001). The highest proportion of women was under 24 years old (38.1%), single (49.5%), with secondary education (53.5%), and living in rural areas (55.4%). BV was associated with young age at first sexual intercourse (44.5%) (χ2 = 17.47, p=< 0.001), condom use (43.3%) (χ2 =3.7, p= 0.05), and no use of contraceptives (49%) (χ2= 13.6, p=0.02). In real-time PCR, a higher proportion of BV cases (47.2%) were detected. However, 12.5% of women had an unknown vaginal dysbiosis. The sensitivity and specificity of the PCR were 99.6% and 82.2%, respectively. Using the PCR as a reference test, the sensitivity and specificity of the Nugent score were 86.2% and 99.4%, respectively. The concordance of both tests was κ=0.825 (95% CI, 0.78 - 0.86), p<0.001.

Conclusions: A high prevalence of BV was associated with young age at first sexual intercourse, condom and contraceptive use among women in Maputo, Mozambique. The AmpliSens® Florocenosis/Bacterial vaginosis-FRT PCR assay detected more BV-positive cases than the Nugent score and needs further evaluation in other settings.

Place, publisher, year, edition, pages
Lippincott Williams & Wilkins, 2024
National Category
Infectious Medicine
Identifiers
urn:nbn:se:oru:diva-111545 (URN)001145322900547 ()
Conference
Annual Meeting of the Infectious-Diseases-Society-for-Obstetrics-and-Gynecology (IDSOG), Boston, MA, USA, August 4-6, 2022
Available from: 2024-02-16 Created: 2024-02-16 Last updated: 2024-02-16Bibliographically approved
Sangprasert, P., Golparian, D., Paopang, P., Girdthep, N., Lawung, R., Gopinath, D., . . . Unemo, M. (2024). Complete reference genomes of two ceftriaxone-resistant Neisseria gonorrhoeae strains identified in routine surveillance in Bangkok, Thailand, using Nanopore Q20+ chemistry, VolTRAX V2b, and Illumina sequencing. Microbiology Resource Announcements, Article ID e0123123.
Open this publication in new window or tab >>Complete reference genomes of two ceftriaxone-resistant Neisseria gonorrhoeae strains identified in routine surveillance in Bangkok, Thailand, using Nanopore Q20+ chemistry, VolTRAX V2b, and Illumina sequencing
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2024 (English)In: Microbiology Resource Announcements, E-ISSN 2576-098X, article id e0123123Article in journal (Refereed) Epub ahead of print
Abstract [en]

Ceftriaxone-resistant Neisseria gonorrhoeae strains, mostly associated with Asia, threaten gonorrhea treatment. We report the reference genomes of two ceftriaxone-resistant isolates found in routine surveillance in Bangkok, Thailand. The genomes belonged to the more antimicrobial-susceptible genomic lineage B, illustrating that both ceftriaxone-resistant strains and the mosaic penA-60.001 ceftriaxone-resistance determinant are spreading.

Place, publisher, year, edition, pages
American Society for Microbiology, 2024
Keywords
Neisseria gonorrhoeae, Thailand, ceftriaxone resistance
National Category
Infectious Medicine
Identifiers
urn:nbn:se:oru:diva-111350 (URN)10.1128/mra.01231-23 (DOI)001155697800001 ()38299807 (PubMedID)
Funder
Region Örebro County
Note

The present work was funded by grants from the Bangrak STIs Center, Bangkok, Thailand; WHO Thailand; Örebro County Council Research Committee; and the Foundation for Medical Research at Örebro University Hospital, Sweden.

Available from: 2024-02-02 Created: 2024-02-02 Last updated: 2024-02-14Bibliographically approved
Somajo, S., Nilsson, F., Ekelund, O. & Unemo, M. (2024). Detection of antimicrobial resistance in <5 h in Neisseria gonorrhoeae isolates using flow cytometry-proof of concept for seven clinically relevant antimicrobials. Journal of Antimicrobial Chemotherapy, Article ID dkae034.
Open this publication in new window or tab >>Detection of antimicrobial resistance in <5 h in Neisseria gonorrhoeae isolates using flow cytometry-proof of concept for seven clinically relevant antimicrobials
2024 (English)In: Journal of Antimicrobial Chemotherapy, ISSN 0305-7453, E-ISSN 1460-2091, article id dkae034Article in journal (Refereed) Epub ahead of print
Abstract [en]

Introduction: Antimicrobial resistance in Neisseria gonorrhoeae compromises gonorrhoea treatment and rapid antimicrobial susceptibility testing (AST) would be valuable. We have developed a rapid and accurate flow cytometry method (FCM) for AST of gonococci.

Methods: The 2016 WHO gonococcal reference strains, and WHO Q, R and S (n = 17) were tested against seven clinically relevant antibiotics (ceftriaxone, cefixime, azithromycin, spectinomycin, ciprofloxacin, tetracycline and gentamicin). After 4.5 h incubation of inoculated broth, the fluorescent dye Syto (TM) 9 was added, followed by FCM analysis. After gating, the relative remaining population of gonococci, compared with unexposed growth control samples, was plotted against antimicrobial concentration, followed by non-linear curve regression analysis. Furthermore, the response at one single concentration/tested antibiotic was evaluated with the intention to use as a screening test for detection of resistant gonococci.

Results: A dose-dependent response was seen in susceptible isolates for all tested antimicrobials. There was a clear separation between susceptible/WT and resistant/non-WT isolates for ceftriaxone, cefixime, spectinomycin, ciprofloxacin and tetracycline. In contrast, for azithromycin, only high-level-resistant isolates were distinguished, while resistant isolates with MICs of 4 mg/L were indistinguishable from WT (MIC <= 1 mg/L) isolates. For gentamicin, all tested 17 isolates were WT and FCM analysis resulted in uniform dose-response curves. Using a single antibiotic concentration and a 50% remaining cell population cut-off, the overall sensitivity and specificity for resistance detection were 93% and 99%, respectively.

Conclusions: By providing results in <5 h for gonococcal isolates, FCM-based AST can become a rapid screening method for antimicrobial resistance or antimicrobial susceptibility in gonococci.

Place, publisher, year, edition, pages
Oxford University Press, 2024
National Category
Medical Biotechnology (with a focus on Cell Biology (including Stem Cell Biology), Molecular Biology, Microbiology, Biochemistry or Biopharmacy)
Identifiers
urn:nbn:se:oru:diva-111647 (URN)10.1093/jac/dkae034 (DOI)001160693500001 ()38334417 (PubMedID)
Funder
Region Kronoberg, 961293; 988785
Available from: 2024-02-19 Created: 2024-02-19 Last updated: 2024-02-20Bibliographically approved
Matthyssen, T., Celentano, A., Hocking, J., Kong, F. Y., McCullough, M., Paolini, R., . . . Williamson, D. (2024). Development of a novel human oral tissue model of gonorrhoea. Paper presented at Annual Meeting of the Infectious-Diseases-Society-for-Obstetrics-and-Gynecology (IDSOG), Boston, MA, USA, August 4-6, 2022. Sexually Transmitted Diseases, 51(1S), S123-S124, Article ID P73.
Open this publication in new window or tab >>Development of a novel human oral tissue model of gonorrhoea
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2024 (English)In: Sexually Transmitted Diseases, ISSN 0148-5717, E-ISSN 1537-4521, Vol. 51, no 1S, p. S123-S124, article id P73Article in journal, Meeting abstract (Other academic) Published
Abstract [en]

Background: Oropharyngeal Neisseria gonorrhoeae (NG) infections are common, increasing, and have a higher treatment failure compared with other infection sites. Due to antimicrobial resistance, NG has become a global public health threat as available treatments remain scarce. Little is known about where NG colonizes in the oral mucosa and therefore, where antibiotics need to be distributed to cure infection. A recent review also highlighted the lack of oral cell models available for investigating NG infection. We recently started creating an in-vitroco-culture model for NG strains with human oral epithelial cells to understand patterns of NG growth in the mouth and examine antibiotic uptake by oral cell types supporting NG growth.

Methods: NG strains were grown on Chocolate agar with IsoVitaleX and in modified Fastidious broth media in optimised conditions. NG colonies were assessed using a colony counter (Scan1200, Interscience technology). In a 2D model, NG were co-cultured with 4 human oral keratinocyte cell lines isolated from different anatomical subsites of theoral cavity. Intra- and extra-cellular NG was quantified, and intracellular spatial distribution was assessed with confocal microscopy and immunocytochemistry. Invasion into 3D spheroids was characterised with penetration depth assessed via histological analysis (haematoxylin and eosin staining) and immunocytochemistry with images taken on a Zeiss Axioscan7 slide scanner or LSM80 0confocal microscope. Real time invasion into spheroids was imaged using a MuviCyte live-cell imaging system. Lastly, host cell viability in response to NG infection was also assessed.

Results: We created the first-of-its-kind in-vitro model for NG oral infection demonstrating that it is possible to co-culture NG with oral derived cells. NG survives and infects oral cells in an in vitro setting in both 2D and 3D models. Different strains of NG infected oral cells to significantly different degrees.

Conclusion: Our presented model can be used to explore the interactions of NG with oral tissues and to investigate current and new therapeutics against oropharyngeal gonorrhoea. 

Place, publisher, year, edition, pages
Lippincott Williams & Wilkins, 2024
National Category
Infectious Medicine
Identifiers
urn:nbn:se:oru:diva-111543 (URN)001145322900157 ()
Conference
Annual Meeting of the Infectious-Diseases-Society-for-Obstetrics-and-Gynecology (IDSOG), Boston, MA, USA, August 4-6, 2022
Available from: 2024-02-16 Created: 2024-02-16 Last updated: 2024-02-16Bibliographically approved
Oeser, C., Beddows, S., Chang, G., Clifton, S., Conolly, A., David, A., . . . Unemo, M. (2024). Feasibility and acceptability of home-based self-collection of multiple vaginal swabs in a general population survey in Britain′s fourth National Survey of Sexual Attitudes and Lifestyles-4 (Natsal-4). Paper presented at Annual Meeting of the Infectious-Diseases-Society-for-Obstetrics-and-Gynecology (IDSOG), Boston, MA, USA, August 4-6, 2022. Sexually Transmitted Diseases, 51(1S), S318-S319, Article ID P325.
Open this publication in new window or tab >>Feasibility and acceptability of home-based self-collection of multiple vaginal swabs in a general population survey in Britain′s fourth National Survey of Sexual Attitudes and Lifestyles-4 (Natsal-4)
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2024 (English)In: Sexually Transmitted Diseases, ISSN 0148-5717, E-ISSN 1537-4521, Vol. 51, no 1S, p. S318-S319, article id P325Article in journal, Meeting abstract (Other academic) Published
Abstract [en]

Background: Despite greater sensitivity of vaginal swabs compared to urine for detection of STIs and high acceptability in clinical settings, acceptability and feasibility of home-based self-collected vaginal swabs for research are less certain. We undertook development work to test these attributes for self-collected vaginal swabs for Natsal-4, a probability sample, interviewer-administered, survey of the ritish population aged 16-59 years.

Methods: We conducted two pilot studies in 2021-22. After completing an interview, all participants identifying as cisgender women were invited to provide three self-collected vaginal swabs, with procedures for providing samples during or afte rface-to-face interviews or after remote interviews. Samples were posted to the laboratory. Consent was provided with the understanding of non-return of results. Participants declining vaginal swabs were invited to provide urine. Interviewers were not clinically trained. Qualitative follow-up interviews were conducted with participants and interviewers provided feedback.

Results: Of the 153 cisgender women interviewed, 77 (50%) agreed to provide a vaginal swab, and 22 preferred to provide urine, resulting in an overall biosample consent rate of 65%. Of these, 60 swabs and 18 urine samples were received (Figure), resulting in an overall response of 51% (39% for vaginal swabs). Of the 77 who consented to provide swabs, 43 (56%) were during face-to-face interviews, of which 95% were received, compared to 13 (17%) agreeing to collection after face-to-face with 54% received, and 21 (27%) choosing remote interviews with 57% received. Fourteen participants (10 provided swabs) gave follow-up interviews and seven interviewers provided feedback. Participants conveyed their motivation to support research by giving samples. Interviewers were surprised at participants’ willingness to provide swabs. Reasons for not providing a swab included the belief that it was uncomfortable, too intimate or not relevant for their circumstances, or that urine was easier to collect.

Conclusion: Our findings show that self-collection of vaginal swabs at home facilitated by non-clinically trained interviewers for a population-based probability survey is feasible and acceptable. Mode of interview and timing of sample collection are important as they affect response rate. Vaginal swab collection was incorporated into the main Natsal-4study with similar response to date.

Place, publisher, year, edition, pages
Lippincott Williams & Wilkins, 2024
National Category
Infectious Medicine
Identifiers
urn:nbn:se:oru:diva-111544 (URN)001145322900403 ()
Conference
Annual Meeting of the Infectious-Diseases-Society-for-Obstetrics-and-Gynecology (IDSOG), Boston, MA, USA, August 4-6, 2022
Available from: 2024-02-16 Created: 2024-02-16 Last updated: 2024-02-16Bibliographically approved
Manjate, A., Nilsson, C., Axelsson, M., Lindroth, S., Sirbu, D., Sacarlal, J., . . . Unemo, M. (2024). Laboratory-based evaluation of the 4th-generation AlereTM HIV Combo rapid point-of-care test. PLOS ONE, 19(2), Article ID e0298912.
Open this publication in new window or tab >>Laboratory-based evaluation of the 4th-generation AlereTM HIV Combo rapid point-of-care test
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2024 (English)In: PLOS ONE, E-ISSN 1932-6203, Vol. 19, no 2, article id e0298912Article in journal (Refereed) Published
Abstract [en]

BACKGROUND: Mozambique is a high-prevalence country for HIV and early detection of new HIV infections is crucial for control of the epidemic. We aimed to evaluate the accuracy of the 4th-generation rapid diagnostic test (RDT) AlereTM HIV Combo in detecting acute and seroconverted HIV-infection, among sexually-active women attending three clinical health centers in Maputo, Mozambique.

METHODS: Women aged 14-55 years (n = 920) seeking care at the Mavalane Health Area, Maputo (February 2018-January 2019) were included, and blood specimens sampled. Sociodemographic and sexual behavior data were collected. Point-of-care HIV testing was performed using Alere DetermineTM HIV-1/2 and Uni-GoldTM HIV-1/2. All samples were also tested using Enzygnost® HIV Integral 4 and Innotest® HIV Antigen mAb in laboratory. The 4th-generation RDT AlereTM HIV Combo was evaluated on serum samples in the laboratory. Finally, Innotest® HIV Antigen mAb, Enzygnost® HIV Integral 4 (Ag/Ab), and HIV RNA quantification acted as gold standard assays in the evaluation of AlereTM HIV Combo test for HIV antigen detection (in clinical samples and in three HIV-1 seroconversion panels).

RESULTS: The antibody component of the 4th generation AlereTM HIV Combo RDT demonstrated a sensitivity and specificity of 100% examining clinical samples. However, the test did not detect HIV p24 antigen in any clinical samples, while Innotest® HIV Antigen mAb, verified by Enzygnost® HIV Integral 4 (Ag/Ab) and/or HIV RNA quantification, detected HIV antigen in six clinical samples. Furthermore, the AlereTM HIV Combo RDT had a low sensitivity in the detection of HIV p24 antigen in seroconversion panels. The HIV prevalence among the examined women was 17.8%.

CONCLUSIONS: The 4th-generation RDT AlereTM HIV Combo showed similar sensitivity to the 3rd-generation RDTs to detect seroconverted HIV-infections. However, the sensitivity for detection of HIV p24 antigen and diagnosing acute HIV infections, before seroconversion, was low. There is an urgent need to develop and evaluate simple and affordable POC tests with high sensitivity and specificity for diagnosing individuals with acute HIV infection in resource-limited settings with high HIV prevalence.

Place, publisher, year, edition, pages
Public Library of Science (PLoS), 2024
National Category
Infectious Medicine
Identifiers
urn:nbn:se:oru:diva-111952 (URN)10.1371/journal.pone.0298912 (DOI)38394120 (PubMedID)
Available from: 2024-02-26 Created: 2024-02-26 Last updated: 2024-02-26Bibliographically approved
Sánchez-Busó, L., Sánchez-Serrano, A., Golparian, D. & Unemo, M. (2024). pyngoST: fast, simultaneous and accurate multiple sequence typing of Neisseria gonorrhoeae genome collections. Microbial Genomics, 10(1)
Open this publication in new window or tab >>pyngoST: fast, simultaneous and accurate multiple sequence typing of Neisseria gonorrhoeae genome collections
2024 (English)In: Microbial Genomics, E-ISSN 2057-5858, Vol. 10, no 1Article in journal (Refereed) Published
Abstract [en]

Extensive gonococcal surveillance has been performed using molecular typing at global, regional, national and local levels. The three main genotyping schemes for this pathogen, multi-locus sequence typing (MLST), Neisseria gonorrhoeae multi-antigen sequence typing (NG-MAST) and N. gonorrhoeae sequence typing for antimicrobial resistance (NG-STAR), allow inter-laboratory and inter-study comparability and reproducibility and provide an approximation to the gonococcal population structure. With whole-genome sequencing (WGS), we obtain a substantially higher and more accurate discrimination between strains compared to previous molecular typing schemes. However, WGS remains unavailable or not affordable in many laboratories, and thus bioinformatic tools that allow the integration of data among laboratories with and without access to WGS are imperative for a joint effort to increase our understanding of global pathogen threats. Here, we present pyngoST, a command-line Python tool for fast, simultaneous and accurate sequence typing of N. gonorrhoeae from WGS assemblies. pyngoST integrates MLST, NG-MAST and NG-STAR, and can also designate NG-STAR clonal complexes, NG-MAST genogroups and penA mosaicism, facilitating multiple sequence typing from large WGS assembly collections. Exact and closest matches for existing alleles and sequence types are reported. The implementation of a fast multi-pattern searching algorithm allows pyngoST to be rapid and report results on 500 WGS assemblies in under 1 min. The mapping of typing results on a core genome tree of 2375 gonococcal genomes revealed that NG-STAR is the scheme that best represents the population structure of this pathogen, emphasizing the role of antimicrobial use and antimicrobial resistance as a driver of gonococcal evolution. This article contains data hosted by Microreact.

Place, publisher, year, edition, pages
Microbiology Society, 2024
Keywords
Genome assemblies, Neisseria gonorrhoeae, population structure, sequence typing
National Category
Infectious Medicine
Identifiers
urn:nbn:se:oru:diva-111227 (URN)10.1099/mgen.0.001189 (DOI)38288762 (PubMedID)
Note

This work was supported by the Spanish Ministry of Science and Innovation (PID2020-120113RA-I00/AEI/10.13039/501100011033) and Generalitat Valenciana (CDEI-06/20-B, Conselleria de Sanitat Universal i Salut Pública; and CISEJI/2022/66, Conselleria d’Innovació, Universitats, Ciència i Societat Digital), Valencia, Spain. A.S.S. was the recipient of a predoctoral fellowship from the Spanish Ministry of Science and Innovation (PRE2021-098199).

Available from: 2024-01-31 Created: 2024-01-31 Last updated: 2024-01-31Bibliographically approved
Bížová, B., Procházka, P., Nyčová, E., Bořil, P., Kubele, J., Poláková, A., . . . Rob, F. (2024). Single-dose cefixime 800 mg plus doxycycline 100 mg b.i.d. for 7 days compared to single-dose ceftriaxone 1 g plus single-dose azithromycin 2 g for treatment of urogenital, rectal and pharyngeal gonorrhoea: A randomised clinical trial. Clinical Microbiology and Infection, 30(2), 211-215
Open this publication in new window or tab >>Single-dose cefixime 800 mg plus doxycycline 100 mg b.i.d. for 7 days compared to single-dose ceftriaxone 1 g plus single-dose azithromycin 2 g for treatment of urogenital, rectal and pharyngeal gonorrhoea: A randomised clinical trial
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2024 (English)In: Clinical Microbiology and Infection, ISSN 1198-743X, E-ISSN 1469-0691, Vol. 30, no 2, p. 211-215Article in journal (Refereed) Published
Abstract [en]

OBJECTIVES: To evaluate the efficacy and tolerability of single-dose oral cefixime 800 mg plus oral doxycycline 100 mg b.i.d. for 7 days, compared to recommended single-dose ceftriaxone plus single-dose, oral azithromycin, for treatment of uncomplicated urogenital, rectal or pharyngeal gonorrhoea.

METHODS: A non-inferiority, open-label, multicentre randomised controlled trial was conducted in Prague, Czech Republic. Some 161 patients, 18-65 years of age diagnosed with uncomplicated urogenital, rectal or pharyngeal gonorrhoea by nucleic acid amplification test (NAAT) were randomised to treatment with single-dose cefixime 800 mg plus doxycycline 100 mg b.i.d. for 1 week or single-dose ceftriaxone 1 g intramuscularly plus single-dose azithromycin 2 g. The primary outcome was the number of participants with negative culture and NAAT at 1 week and 3 weeks, respectively, after treatment initiation.

RESULTS: In all, 161 patients were randomised, 152 were included in per-protocol analyses. All 76 (100%; 95% confidence interval [CI], 0.95-1.00) patients treated with ceftriaxone plus azithromycin achieved negative cultures and NAAT after treatment. In the cefixime plus doxycycline arm at week 1, culture was negative in all 76 (100%) patients; at week 3, culture was negative in 70/76 patients (92%; 95%CI, 0.84-0.97) and NAAT negative in 66/76 patients (87%; 95%CI, 0.77-0.94). At week 3, culture and NAAT were negative in 65/76 patients (86%; 95%CI, 0.76-0.93). Per-protocol risk difference was 14.5% (95%CI, 6.56-22.38). All treatment failures observed in the cefixime arm were pharyngeal gonorrhoea cases.

CONCLUSION: The combination of cefixime and doxycycline did not achieve non-inferiority to ceftriaxone and azithromycin for treatment of gonorrhoea when including pharyngeal gonorrhoea. It did, however, show high efficacy for urogenital and rectal gonorrhoea.

Place, publisher, year, edition, pages
European Society of Clinical Microbiology and Infectious Diseases (ESCMID), 2024
Keywords
Azithromycin, Cefixime, Ceftriaxone, Doxycycline, Neisseria gonorrhoeae, Treatment
National Category
Infectious Medicine
Identifiers
urn:nbn:se:oru:diva-109807 (URN)10.1016/j.cmi.2023.11.006 (DOI)37981059 (PubMedID)2-s2.0-85179802572 (Scopus ID)
Available from: 2023-11-20 Created: 2023-11-20 Last updated: 2024-01-30Bibliographically approved
Kakooza, F., Kiggundu, R., Mboowa, G., Kateete, P. D., Nsangi, O. T., Kabahita, J. M., . . . Unemo, M. (2023). Antimicrobial susceptibility surveillance and antimicrobial resistance in Neisseria gonorrhoeae in Africa from 2001 to 2020: A mini-review. Frontiers in Microbiology, 14, Article ID 1148817.
Open this publication in new window or tab >>Antimicrobial susceptibility surveillance and antimicrobial resistance in Neisseria gonorrhoeae in Africa from 2001 to 2020: A mini-review
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2023 (English)In: Frontiers in Microbiology, E-ISSN 1664-302X, Vol. 14, article id 1148817Article, review/survey (Refereed) Published
Abstract [en]

Antimicrobial resistance (AMR) in Neisseria gonorrhoeae (NG), compromising gonorrhea treatment, is a global public health concern. Improved, quality-assured NG AMR monitoring at the global level is essential. This mini-review examined NG AMR susceptibility surveillance and AMR data from the African continent from 2001 to 2020. Eligible peer-reviewed publications (n = 30) containing NG AMR data for antimicrobials currently recommended for gonorrhea treatment were included. Overall, very limited NG surveillance and AMR data was available. Furthermore, the NG AMR surveillance studies varied greatly regarding surveillance protocols (e.g., populations and samples tested, sample size, antimicrobials examined), methodologies (e.g., antimicrobial susceptibility testing method [agar dilution, minimum inhibitory concentration (MIC) gradient strip test, disc diffusion test] and interpretative criteria), and quality assurance (internal quality controls, external quality assessments [EQA], and verification of AMR detected). Moreover, most studies examined a suboptimal number of NG isolates, i.e., less than the WHO Global Gonococcal Antimicrobial Surveillance Program (GASP) and WHO Enhanced GASP (EGASP) recommendations of ≥100 isolates per setting and year. The notable inter-study variability and frequently small sample sizes make appropriate inter-study and inter-country comparisons of AMR data difficult. In conclusion, it is imperative to establish an enhanced, standardized and quality-assured NG AMR surveillance, ideally including patient metadata and genome sequencing as in WHO EGASP, in Africa, the region with the highest gonorrhea incidence globally. This will enable the monitoring of AMR trends, detection of emerging AMR, and timely refinements of national and international gonorrhea treatment guidelines. To achieve this aim, national and international leadership, political and financial commitments are imperative.

Place, publisher, year, edition, pages
Frontiers Media S.A., 2023
Keywords
Africa, Neisseria gonorrhoeae, WHO Gonococcal Antimicrobial Surveillance Program (GASP), WHO enhanced GASP (EGASP), antimicrobial resistance, antimicrobial susceptibility surveillance, azithromycin, ceftriaxone
National Category
Infectious Medicine
Identifiers
urn:nbn:se:oru:diva-105686 (URN)10.3389/fmicb.2023.1148817 (DOI)000984400400001 ()37089569 (PubMedID)2-s2.0-85153495013 (Scopus ID)
Available from: 2023-04-25 Created: 2023-04-25 Last updated: 2024-01-17Bibliographically approved
Organisations
Identifiers
ORCID iD: ORCID iD iconorcid.org/0000-0003-1710-2081

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