Chlamydia Trachomatis Infection Clinical Trial
— NGS-ISTOfficial title:
Assess the Performance of Metagenomic Sequencing in the Diagnosis of STI (NGS-IST)
NCT number | NCT05581160 |
Other study ID # | IMEA62 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | July 11, 2022 |
Est. completion date | June 30, 2025 |
The main objective of the study will be to assess the performance of the Next-Generation-Sequencing (NGS) diagnostics of Chlamydia trachomatis and Neisseria gonorrhoeae compared to reference techniques.
Status | Recruiting |
Enrollment | 332 |
Est. completion date | June 30, 2025 |
Est. primary completion date | September 30, 2024 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age = 18 years old - MSM - PrEP users - Acceptance of study constraints - With or without Social Security scheme or State Medical Aid - Signature of consent form to participate in the study Exclusion Criteria: - Language barrier making questioning impossible. |
Country | Name | City | State |
---|---|---|---|
France | Service des Maladies Infectieuses et Tropicales Hôpital Saint-Antoine | Paris | |
France | Service des Maladies Infectieuses et Tropicales Hôpital Tenon | Paris |
Lead Sponsor | Collaborator |
---|---|
Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba | ANRS, Emerging Infectious Diseases |
France,
Abdool Karim Q, Abdool Karim SS, Frohlich JA, Grobler AC, Baxter C, Mansoor LE, Kharsany AB, Sibeko S, Mlisana KP, Omar Z, Gengiah TN, Maarschalk S, Arulappan N, Mlotshwa M, Morris L, Taylor D; CAPRISA 004 Trial Group. Effectiveness and safety of tenofovir gel, an antiretroviral microbicide, for the prevention of HIV infection in women. Science. 2010 Sep 3;329(5996):1168-74. doi: 10.1126/science.1193748. Epub 2010 Jul 19. Erratum In: Science. 2011 Jul 29;333(6042):524. — View Citation
Chaix ML, Charreau I, Pintado C, Delaugerre C, Mahjoub N, Cotte L, Capitant C, Raffi F, Cua E, Pialoux G, Tremblay C, Meyer L, Molina JM; ANRS IPERGAY Study Group. Effect of On-Demand Oral Pre-exposure Prophylaxis With Tenofovir/Emtricitabine on Herpes Simplex Virus-1/2 Incidence Among Men Who Have Sex With Men: A Substudy of the ANRS IPERGAY Trial. Open Forum Infect Dis. 2018 Nov 8;5(11):ofy295. doi: 10.1093/ofid/ofy295. eCollection 2018 Nov. — View Citation
Deschamps O, Ortonne N, Hue S, Rodriguez C, Deschodt C, Hirsch G, Colin A, Gregoire L, Delfau-Larue MH, Chosidow O, Wolkenstein P, Ingen-Housz-Oro S. Acute exanthemas: a prospective study of 98 adult patients with an emphasis on cytokinic and metagenomic investigation. Br J Dermatol. 2020 Feb;182(2):355-363. doi: 10.1111/bjd.18166. Epub 2019 Aug 9. — View Citation
Fourati S, Rodriguez C, Hezode C, Soulier A, Ruiz I, Poiteau L, Chevaliez S, Pawlotsky JM. Frequent Antiviral Treatment Failures in Patients Infected With Hepatitis C Virus Genotype 4, Subtype 4r. Hepatology. 2019 Feb;69(2):513-523. doi: 10.1002/hep.30225. Epub 2019 Jan 5. — View Citation
Hernando Rovirola C, Spiteri G, Sabido M, Montoliu A, Gonzalez V, Casabona J, Cole MJ, Noori T, Unemo M. Antimicrobial resistance in Neisseria gonorrhoeae isolates from foreign-born population in the European Gonococcal Antimicrobial Surveillance Programme. Sex Transm Infect. 2020 May;96(3):204-210. doi: 10.1136/sextrans-2018-053912. Epub 2020 Feb 4. — View Citation
Hoornenborg E, Coyer L, Achterbergh RCA, Matser A, Schim van der Loeff MF, Boyd A, van Duijnhoven YTHP, Bruisten S, Oostvogel P, Davidovich U, Hogewoning A, Prins M, de Vries HJC; Amsterdam PrEP Project team in the HIV Transmission Elimination AMsterdam (H-TEAM) Initiative. Sexual behaviour and incidence of HIV and sexually transmitted infections among men who have sex with men using daily and event-driven pre-exposure prophylaxis in AMPrEP: 2 year results from a demonstration study. Lancet HIV. 2019 Jul;6(7):e447-e455. doi: 10.1016/S2352-3018(19)30136-5. Epub 2019 Jun 6. — View Citation
Looker KJ, Elmes JAR, Gottlieb SL, Schiffer JT, Vickerman P, Turner KME, Boily MC. Effect of HSV-2 infection on subsequent HIV acquisition: an updated systematic review and meta-analysis. Lancet Infect Dis. 2017 Dec;17(12):1303-1316. doi: 10.1016/S1473-3099(17)30405-X. Epub 2017 Aug 23. — View Citation
Molina JM, Charreau I, Chidiac C, Pialoux G, Cua E, Delaugerre C, Capitant C, Rojas-Castro D, Fonsart J, Bercot B, Bebear C, Cotte L, Robineau O, Raffi F, Charbonneau P, Aslan A, Chas J, Niedbalski L, Spire B, Sagaon-Teyssier L, Carette D, Mestre SL, Dore V, Meyer L; ANRS IPERGAY Study Group. Post-exposure prophylaxis with doxycycline to prevent sexually transmitted infections in men who have sex with men: an open-label randomised substudy of the ANRS IPERGAY trial. Lancet Infect Dis. 2018 Mar;18(3):308-317. doi: 10.1016/S1473-3099(17)30725-9. Epub 2017 Dec 8. — View Citation
Nieuwenhuis RF, Ossewaarde JM, Gotz HM, Dees J, Thio HB, Thomeer MG, den Hollander JC, Neumann MH, van der Meijden WI. Resurgence of lymphogranuloma venereum in Western Europe: an outbreak of Chlamydia trachomatis serovar l2 proctitis in The Netherlands among men who have sex with men. Clin Infect Dis. 2004 Oct 1;39(7):996-1003. doi: 10.1086/423966. Epub 2004 Sep 8. — View Citation
Ong JJ, Baggaley RC, Wi TE, Tucker JD, Fu H, Smith MK, Rafael S, Anglade V, Falconer J, Ofori-Asenso R, Terris-Prestholt F, Hodges-Mameletzis I, Mayaud P. Global Epidemiologic Characteristics of Sexually Transmitted Infections Among Individuals Using Preexposure Prophylaxis for the Prevention of HIV Infection: A Systematic Review and Meta-analysis. JAMA Netw Open. 2019 Dec 2;2(12):e1917134. doi: 10.1001/jamanetworkopen.2019.17134. — View Citation
Rodriguez C, Gricourt G, Ndebi M, Demontant V, Poiteau L, Burrel S, Boutolleau D, Woerther PL, Calvez V, Stroer S, Pawlotsky JM. Fatal Encephalitis Caused by Cristoli Virus, an Emerging Orthobunyavirus, France. Emerg Infect Dis. 2020 Jun;26(6):1287-1290. doi: 10.3201/eid2606.191431. — View Citation
Rodriguez C, Jary A, Hua C, Woerther PL, Bosc R, Desroches M, Sitterle E, Gricourt G, De Prost N, Pawlotsky JM, Chosidow O, Sbidian E, Decousser JW; Multidisciplinary Necrotizing Fasciitis Study Group. Pathogen identification by shotgun metagenomics of patients with necrotizing soft-tissue infections. Br J Dermatol. 2020 Jul;183(1):105-113. doi: 10.1111/bjd.18611. Epub 2019 Dec 2. — View Citation
Sitterle E, Rodriguez C, Mounier R, Calderaro J, Foulet F, Develoux M, Pawlotsky JM, Botterel F. Contribution of Ultra Deep Sequencing in the Clinical Diagnosis of a New Fungal Pathogen Species: Basidiobolus meristosporus. Front Microbiol. 2017 Mar 7;8:334. doi: 10.3389/fmicb.2017.00334. eCollection 2017. — View Citation
Surgers L, Chiarabini T, Royer G, Rougier H, Mercier-Darty M, Decre D, Valin N, Woerther PL, Decousser JW, Girard PM, Lacombe K, Boyd A. Evidence of Sexual Transmission of Extended-Spectrum beta-Lactamase-Producing Enterobacterales: A Cross-sectional and Prospective Study. Clin Infect Dis. 2022 Oct 29;75(9):1556-1564. doi: 10.1093/cid/ciac218. — View Citation
Unemo M, Shafer WM. Antimicrobial resistance in Neisseria gonorrhoeae in the 21st century: past, evolution, and future. Clin Microbiol Rev. 2014 Jul;27(3):587-613. doi: 10.1128/CMR.00010-14. — View Citation
Van Praet JT, Steyaert S, Vandecasteele S, Van Den Bergh B, Mahieu H, De Buyser S, Grootaert V, Descheemaeker P, Reynders M. Mycoplasma genitalium acquisition and macrolide resistance after initiation of HIV pre-exposure prophylaxis in men who have sex with men. Sex Transm Infect. 2020 Sep;96(6):396-398. doi: 10.1136/sextrans-2019-054335. Epub 2020 Jan 2. — View Citation
Wilson MR, Naccache SN, Samayoa E, Biagtan M, Bashir H, Yu G, Salamat SM, Somasekar S, Federman S, Miller S, Sokolic R, Garabedian E, Candotti F, Buckley RH, Reed KD, Meyer TL, Seroogy CM, Galloway R, Henderson SL, Gern JE, DeRisi JL, Chiu CY. Actionable diagnosis of neuroleptospirosis by next-generation sequencing. N Engl J Med. 2014 Jun 19;370(25):2408-17. doi: 10.1056/NEJMoa1401268. Epub 2014 Jun 4. — View Citation
Wilson MR, Sample HA, Zorn KC, Arevalo S, Yu G, Neuhaus J, Federman S, Stryke D, Briggs B, Langelier C, Berger A, Douglas V, Josephson SA, Chow FC, Fulton BD, DeRisi JL, Gelfand JM, Naccache SN, Bender J, Dien Bard J, Murkey J, Carlson M, Vespa PM, Vijayan T, Allyn PR, Campeau S, Humphries RM, Klausner JD, Ganzon CD, Memar F, Ocampo NA, Zimmermann LL, Cohen SH, Polage CR, DeBiasi RL, Haller B, Dallas R, Maron G, Hayden R, Messacar K, Dominguez SR, Miller S, Chiu CY. Clinical Metagenomic Sequencing for Diagnosis of Meningitis and Encephalitis. N Engl J Med. 2019 Jun 13;380(24):2327-2340. doi: 10.1056/NEJMoa1803396. — View Citation
* Note: There are 18 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To evaluate the performance of NGS metagenomic diagnosis of Chlamydia trachomatis (Ct) and Neisseria gonorrhoeae (Ng) compared to reference techniques. | Sensitivity, specificity, positive and negative predictive values of NGS compared to reference techniques for Ng and Ct. | 12 months | |
Secondary | To evaluate the performance of the diagnosis by NGS of the other STIs compared to the reference techniques. | Sensitivity, specificity, positive and negative predictive values of NGS compared to reference techniques for other sexually transmitted infections (STIs). | 12 months | |
Secondary | Describe the epidemiology of circulating strains by molecular typing. | Total number of cases of Ct, Ng, agents not usually screened for in STI screening compared to the number of subjects at the time of their inclusion in the study cohort, with 95% confidence interval. | 12 months | |
Secondary | Estimate the incidence and describe the natural history of colonization by Mycoplasma genitalium (Mg). | Number of new cases Mycoplasma genitalium (Mg) compared to the number of subjects followed in the study cohort per month of follow-up. | 12 months | |
Secondary | Estimate the incidence of the appearance of Mycoplasma genitalium resistance under antibiotic selection pressure. | Number of new cases Mycoplasma genitalium (Mg) compared to the number of subjects followed in the study cohort per month of follow-up under antibiotic selection pressure. | 12 months | |
Secondary | Characterize circulating Neisseria gonorrhoeae (Ng) clones. | Total number of cases of circulating Neisseria gonorrhoeae (Ng) clones compared to the number of subjects at the time of their inclusion in the study cohort, with 95% confidence interval. | 12 months | |
Secondary | Characterize the circulating serotypes of Chlamydia trachomatis (Ct). | Total number of cases of circulating serotypes of Chlamydia trachomatis (Ct) compared to the number of subjects at the time of their inclusion in the study cohort, with 95% confidence interval. | 12 months | |
Secondary | Estimate the incidence of agents not usually screened for in STI screening (HSV-1, HSV-2, HPV, Mycoplasma hominis, Ureaplasma sp, Haemophilus ducreyi, Campylobacter sp, Shigella sp, Clostridium difficile, Entamoeba histolytica). | Number of new cases of agents not usually tested for in STI screening compared to the number of subjects followed in the study cohort per month of follow-up. | 12 months | |
Secondary | Determine the factors associated with STI events. | Hazard ratio of determinants (factors) associations with the STI cases incidence. | 12 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04269434 -
GonoScreen: Efficacy of Screening STIs in MSM
|
N/A | |
Active, not recruiting |
NCT04139629 -
Cohort Study Investigating the Association Between Antichlamydial Antibody Positivity and ART Outcomes in Women With TFI
|
N/A | |
Completed |
NCT03107377 -
Phase 2B/3 Double-blinded Placebo-controlled
|
Phase 2/Phase 3 | |
Completed |
NCT03098329 -
Check it: A New Approach to Controlling Chlamydia Transmission in Young People
|
N/A | |
Recruiting |
NCT03862495 -
Genital CT Treatment to Pregnant Women to Prevent Adverse Pregnancy Outcomes: A Pilot RCT
|
N/A | |
Completed |
NCT05307991 -
Integrating Enhanced HIV PrEP Into a STI Clinic in Lilongwe
|
||
Terminated |
NCT02083276 -
Mecillinam for Treatment of Genital Chlamydia Infection
|
Phase 2 | |
Active, not recruiting |
NCT06131749 -
Genital Tract Infections, the Vaginal Microbiome and Gestational Age at Birth Among Pregnant Women in South Africa
|
||
Completed |
NCT03568695 -
Detection of Chlamydia Trachomatis, Neisseria Gonorrhoeae and Mycoplasma Genitalium by Real-time Multiplex Polymerase Chain Reaction (PCR) After Pooling Pharyngeal, Anorectal and Urinary Samples
|
N/A | |
Completed |
NCT01448876 -
Incubation Time and Test of Cure of Chlamydia Trachomatis
|
N/A | |
Not yet recruiting |
NCT06369220 -
A Study of the Cobas® Liat CT/NG/MG Test Versus Current Standard Practice for Managing Participants at Increased Risk of Sexually Transmitted Infections
|
N/A | |
Not yet recruiting |
NCT06395675 -
Clinical Evaluation of the ID NOW™ CT/NG Test
|
N/A | |
Completed |
NCT03970850 -
NeuMoDx PrEDiCTiNG Study Evaluation Plan
|
N/A | |
Completed |
NCT01631201 -
Safety and Efficacy Study of Rifalazil for the Treatment of Chlamydia Trachomatis Infection in Women
|
Phase 2 | |
Completed |
NCT05216744 -
Comparison of Efficacy of Two Combination Regimens for the Neisseria Gonorrhoeae and Chlamydia Coinfection
|
Phase 2 | |
Not yet recruiting |
NCT03532464 -
Azithromycin Compared With Doxycycline for Treating Anorectal Chlamydia Trachomatis Infection Concomitant to a Vaginal Infection
|
Phase 4 | |
Not yet recruiting |
NCT06234943 -
Pharmacy-based Testing and Treatment for Gonorrhea and Chlamydia
|
N/A | |
Active, not recruiting |
NCT04050540 -
Doxycycline PEP for Prevention of Sexually Transmitted Infections Among Kenyan Women Using HIV PrEP
|
Phase 4 | |
Completed |
NCT04955717 -
Antenatal Chlamydia Trachomatis and Neisseria Gonorrhoeae Testing to Prevent Adverse Neonatal Consequences
|
N/A | |
Active, not recruiting |
NCT05666778 -
Single Arm Trial of Menstrual Cups Among Economically Vulnerable Women to Reduce Bacterial Vaginosis and STIs
|
Phase 2 |