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NCT04437836: HighRif C
Evaluation of Pharmacokinetics and Safety Tolerability of Higher Doses of Rifampic
Phase 1, PHASE2 trial testing Evaluation of high dose rifampicin in children in Clinical Trial in 31 participants. Completed in 31 December 2023.
30 June 2022
Quick facts
| Lead sponsor | Kilimanjaro Clinical Research Institute |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | crossover |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 31 |
| Start date | 1 July 2019 |
| Primary completion | 30 June 2022 |
| Estimated completion | 31 December 2023 |
| Sites | 4 locations across Tanzania |
Drugs / interventions tested
- Evaluation of high dose rifampicin in children — full drug profile →
Conditions studied
- Clinical Trial — all drugs for Clinical Trial →
Sponsor
Kilimanjaro Clinical Research Institute
Who can join
Adults 1 to 14, any sex, with Clinical Trial. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Tuberculosis in children is a major public health problem and it contributes 10% of the total TB cases worldwide. TB treatment outcomes in children are challenged by insufficient consideration of the relationships between doses administered, concentrations achieved and eventual desirable and undesirable effects (pharmacodynamics) of TB drugs. Rifampicin is a pivotal TB drug and data from adults suggest that a much higher dose of rifampicin (35 mg/kg instead of 10 mg/kg), resulting in much higher rifampicin exposures in plasma, is safe and tolerable and may provide a higher efficacy. The dose needed in children to achieve the same exposure in plasma is unknown.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Pharmacokinetics and safety of high-dose rifampicin in children with TB: the Opti-Rif trial.
Garcia-Prats AJ, Svensson EM, Winckler J, Draper HR, et al · · 2021 · cited 35× · PMID 34529779 · DOI 10.1093/jac/dkab336
Verify or expand the search:
- PubMed search for NCT04437836
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Kilimanjaro Clinical Research Institute trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04437836 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Kilimanjaro Clinical Research Institute
- Last refreshed: 15 February 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04437836.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing