drugset / Trial / NCT04528277
Short Course Rifapentine and Isoniazid for the Preventive Treatment for Latent Genital Tuberculosis
Phase 3
Unknown
1050 enrolled
Huashan Hospital
Shanghai First Maternity and Infant Hospital · collab
Non-randomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to assess the efficacy, safety and tolerability of the 1-month regimen of three times weekly rifapentine plus isoniazid in improving fertility outcome in recurrent implantation failure (RIF) patients with latent genital tuberculosis (LGTB), compared to no treatment and non-LGTB patients.
Timeline
- Start
- 2020-09-01
- Primary completion
- 2021-09-01
- Completion
- 2022-09-01
Publications
- Background Grace GA, Devaleenal DB, Natrajan M. Genital tuberculosis in females. Indian J Med Res. 2017 Apr;145(4):425-436. doi: 10.4103/ijmr.IJMR_1550_15.
- Background Jindal UN, Verma S, Bala Y. Favorable infertility outcomes following anti-tubercular treatment prescribed on the sole basis of a positive polymerase chain reaction test for endometrial tuberculosis. Hum Reprod. 2012 May;27(5):1368-74. doi: 10.1093/humrep/des076. Epub 2012 Mar 14.
- Background Dam P, Shirazee HH, Goswami SK, Ghosh S, Ganesh A, Chaudhury K, Chakravarty B. Role of latent genital tuberculosis in repeated IVF failure in the Indian clinical setting. Gynecol Obstet Invest. 2006;61(4):223-7. doi: 10.1159/000091498. Epub 2006 Feb 13.
- Background Jirge PR, Chougule SM, Keni A, Kumar S, Modi D. Latent genital tuberculosis adversely affects the ovarian reserve in infertile women. Hum Reprod. 2018 Jul 1;33(7):1262-1269. doi: 10.1093/humrep/dey117.
- Background Bagchi B, Chatterjee S, Gon Chowdhury R. Role of latent female genital tuberculosis in recurrent early pregnancy loss: A retrospective analysis. Int J Reprod Biomed. 2019 Dec 30;17(12):929-934. doi: 10.18502/ijrm.v17i12.5799. eCollection 2019 Dec.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Isoniazid | Small molecule | 400 mg | Oral |
| Subject | Rifapentine | Small molecule | 450 mg | Oral |