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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03568695
Other study ID # CHRO-2018-01
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 29, 2018
Est. completion date June 16, 2020

Study information

Verified date August 2020
Source Centre Hospitalier Régional d'Orléans
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study aims to compare the sensitivity of detecting Chlamydia trachomatis, Neisseria gonorrhoeae and Mycoplasma genitalium by real-time multiplex PCR in a pooled analysis (i.e. gathering pharyngeal, anorectal and urinary samples) versus the standard of care (where a real-time multiplex PCR is made in each of the three samples).


Description:

Patients detected positive for one of the three (Sexually Transmitted Infection)STIs (Chlamydia trachomatis, Neisseria gonorrhoeae or Mycoplasma genitalium) on one site will be re-sampled twice at each of the three sites (pharynx, rectum, urine) before receiving antibiotics. Then, a real-time multiplex PCR will be performed on the pooled sample (merging pharyngeal, anorectal and urinary samples) versus on each of the three samples separately (i.e. standard of care) to compare both sensitivities.


Recruitment information / eligibility

Status Completed
Enrollment 166
Est. completion date June 16, 2020
Est. primary completion date June 16, 2020
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patient having provided a written consent;

- Patient age > 18 years;

- Man who have sex with men tested positive for one the three STIs : Chlamydia trachomatis, Neisseria gonorrhoeae or Mycoplasma genitalium

- Covered by health insurance

Exclusion Criteria:

- Being under tutorship

- Being deprived of liberty

- Patient who received antibiotic treatment prior to study inclusion and re-sampling

Study Design


Intervention

Diagnostic Test:
Two samples on each of the three sites (pharynx, rectum, urine)
two new samples on each of the three sites (pharynx, rectum, urine) which will make it possible to compare the difference of sensitivity between real-time multiplex PCR from pools of 3 samples and the usual technique .

Locations

Country Name City State
France CH de Niort Niort
France CHR d'Orleans Orléans
France CHU de Poitiers Poitiers
France CH Laennec Quimper
France CHU de Tours Tours

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Régional d'Orléans

Country where clinical trial is conducted

France, 

References & Publications (4)

Kacena KA, Quinn SB, Hartman SC, Quinn TC, Gaydos CA. Pooling of urine samples for screening for Neisseria gonorrhoeae by ligase chain reaction: accuracy and application. J Clin Microbiol. 1998 Dec;36(12):3624-8. — View Citation

Kacena KA, Quinn SB, Howell MR, Madico GE, Quinn TC, Gaydos CA. Pooling urine samples for ligase chain reaction screening for genital Chlamydia trachomatis infection in asymptomatic women. J Clin Microbiol. 1998 Feb;36(2):481-5. — View Citation

La Ruche G, Le Strat Y, Fromage M, Berçot B, Goubard A, de Barbeyrac B, Sednaoui P, Cambau E, Lot F. Incidence of gonococcal and chlamydial infections and coverage of two laboratory surveillance networks, France, 2012. Euro Surveill. 2015 Aug 13;20(32):6-15. — View Citation

Lewis JL, Lockary VM, Kobic S. Cost savings and increased efficiency using a stratified specimen pooling strategy for Chlamydia trachomatis and Neisseria gonorrhoeae. Sex Transm Dis. 2012 Jan;39(1):46-8. doi: 10.1097/OLQ.0b013e318231cd4a. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary To evaluate the sensitivity of Chlamydia trachomatis, Neisseria gonorrhoeae and Mycoplasma genitalium detection in a pooled analysis Sensitivity rates will be compared using non parametric statistical analysis. The pooling method will be considered as acceptable if the sensitivity reach at least 95%. Day 1
Secondary Impact of the strategies on the costs Costs will include time of lab staff, DNA extraction, PCR material in the two strategies and related to 1000 patients Day 1
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