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| Content Provider | Springer Nature : BioMed Central |
|---|---|
| Author | Atwine, Daniel Orikiriza, Patrick Taremwa, Ivan Ayebare, Arnold Logoose, Suzan Mwanga-Amumpaire, Juliet Jindani, Amina Bonnet, Maryline |
| Abstract | Background Estimates of month-2 culture conversion, a proxy indicator of tuberculosis (TB) treatment efficacy in phase-2 trials can vary by culture-type and geographically with lower rates reported among African sites. The sub-study aimed at comparing TB detection rates of different culture media, within and across rifampicin-based regimens (R10, 15 and 20 mg/Kg) over a 6-month treatment follow-up period, and to establish predictors of month-2 culture non-conversion among HIV-negative TB patients enrolled at RIFATOX trial site in Uganda. Methods Unlike in other Rifatox Trial sites, it is only in Uganda were Lowenstein-Jensen (LJ) and Mycobacteria growth indicator tube (MGIT) were used throughout 6-months for treatment monitoring. Conversion rates were compared at month-2, 4 and 6 across cultures and treatment-type. Binomial regression analysis performed for predictors of month-2 non-conversion. Results Of the 100 enrolled patients, 45% had converted based on combined LJ and MGIT by month-2, with no significant differences across treatment arms, p = 0.721. LJ exhibited higher conversion rates than MGIT at month-2 (58.4% vs 56.0%, p = 0.0707) and month-4 (98.9% vs 88.4%, p = 0.0391) respectively, more so within the high-dose rifampicin arms. All patients had converted by month-6. Time-to-TB detection (TTD) on MGIT and social service jobs independently predict month-2 non-conversion. Conclusion The month-2 culture conversion used in phase 2 clinical trials as surrogate marker of treatment efficacy is influenced by the culture method used for monitoring mycobacterial response to TB treatment. Therefore, multi-centric TB therapeutic trials using early efficacy endpoint should use the same culture method across sites. The Time-to-detection of MTB on MGIT prior to treatment and working in Social service jobs bear an increased risk of culture non-conversion at month-2. Trial registration ISRCTN ISRCTN55670677 . Registered 09th November 2010. Retrospectively registered. |
| Related Links | https://bmcinfectdis.biomedcentral.com/counter/pdf/10.1186/s12879-017-2335-7.pdf |
| Ending Page | 8 |
| Page Count | 8 |
| Starting Page | 1 |
| File Format | HTM / HTML |
| ISSN | 14712334 |
| DOI | 10.1186/s12879-017-2335-7 |
| Journal | BMC Infectious Diseases |
| Issue Number | 1 |
| Volume Number | 17 |
| Language | English |
| Publisher | BioMed Central |
| Publisher Date | 2017-04-24 |
| Access Restriction | Open |
| Subject Keyword | Infectious Diseases Parasitology Medical Microbiology Tropical Medicine Internal Medicine Delayed culture conversion Efficacy HIV-negative TB patients Time-to-detection Treatment failure |
| Content Type | Text |
| Resource Type | Article |
| Subject | Infectious Diseases |
| Journal Impact Factor | 3.4/2023 |
| 5-Year Journal Impact Factor | 3.3/2023 |
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