Trial reportAntimicrobial agents and chemotherapy2010
Pharmacokinetics of rifampin and clarithromycin in patients treated for Mycobacterium ulcerans infection.
Trial report in Antimicrobial agents and chemotherapy, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 27 papers, 3 of them syntheses that pooled it.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
27 citing papers in PubMed, 3 syntheses or guidelines pooled it, 58 citations in OpenAlex.
- Drugs for treating Buruli ulcer (Mycobacterium ulcerans disease).The Cochrane database of systematic reviews · 2018Pooled it
- Lack of Clinical Pharmacokinetic Studies to Optimize the Treatment of Neglected Tropical Diseases: A Systematic Review.Clinical pharmacokinetics · 2017Pooled it
- Clinical efficacy of Rifampicin and Streptomycin in combination against Mycobacterium ulcerans infection: a systematic review.The Pan African medical journal · 2013Pooled it
- Rifampicin and clarithromycin (extended release) versus rifampicin and streptomycin for limited Buruli ulcer lesions: a randomised, open-label, non-inferiority phase 3 trial.Lancet (London, England) · 2020Trial
- Association of Antimicrobial Susceptibility with Treatment Response inPathogens (Basel, Switzerland) · 2025Article
- Review
- Therapeutic drug monitoring of docetaxel administered for breast cancer in a patient receiving rifampicin and clarithromycin to treat nontuberculous mycobacteriosis: A case report.Molecular and clinical oncology · 2025Article
- Optimizing β-lactam-containing antibiotic combination therapy for the treatment of Buruli ulcer.British journal of clinical pharmacology · 2025Article
- Pharmacokinetics of extended-release clarithromycin in patients with Mycobacterium ulcerans infection.Scientific reports · 2024Article
- Amoxicillin/clavulanate in combination with rifampicin/clarithromycin is bactericidal against Mycobacterium ulcerans.PLoS neglected tropical diseases · 2024Article
- An Overview of Various Rifampicin Analogs againstMedicinal chemistry (Shariqah (United Arab Emirates)) · 2024Review
- Article
- Risk Factors Associated with Antibiotic Treatment Failure of Buruli Ulcer.Antimicrobial agents and chemotherapy · 2020Observational
- Pharmacologic management ofExpert review of clinical pharmacology · 2020Review
- Effect of rifampicin and clarithromycin on the CYP3A activity in patients withJournal of thoracic disease · 2019Article
- Oxazolidinones Can Replace Clarithromycin in Combination with Rifampin in a Mouse Model of Buruli Ulcer.Antimicrobial agents and chemotherapy · 2019Article
- Treatment for Buruli ulcer: the long and winding road to antimicrobials-first.The Cochrane database of systematic reviews · 2018Article
- Shorter-course treatment for Mycobacterium ulcerans disease with high-dose rifamycins and clofazimine in a mouse model of Buruli ulcer.PLoS neglected tropical diseases · 2018Article
- Increasing Experience with Primary Oral Medical Therapy for Mycobacterium ulcerans Disease in an Australian Cohort.Antimicrobial agents and chemotherapy · 2016Article
- Probable Buruli Ulcer Disease in Honduras.Open forum infectious diseases · 2016Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors at 4 institutions in 4 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
In a randomized controlled trial in Ghana, treatment of Mycobacterium ulcerans infection with streptomycin (SM)-rifampin (RIF) for 8 weeks was compared with treatment with SM-RIF for 4 weeks followed by treatment with RIF-clarithromycin (CLA) for 4 weeks. The extent of the interaction of RIF and CLA combined on the pharmacokinetics of the two compounds is unknown in this population and was therefore studied in a subset of patients. Patients received CLA at a dose of 7.5 mg/kg of body weight once daily, rounded to the nearest 125 mg. RIF was administered at a dose of 10 mg/kg, rounded to the nearest 150 mg. SM was given at a dose of 15 mg/kg once daily as an intramuscular injection. Plasma samples were drawn at steady state and analyzed by liquid chromatography-tandem mass spectroscopy. Pharmacokinetic parameters were calculated with the MW/Pharm (version 3.60) program. Comedication with CLA resulted in a 60% statistically nonsignificant increase in the area under the plasma concentration-time curve (AUC) for RIF of 25.8 mg x h/liter (interquartile ratio [IQR], 21.7 to 31.5 mg x h/liter), whereas the AUC of RIF was 15.2 mg x h/liter (IQR, 15.0 to 17.5 mg x h/liter) in patients comedicated with SM (P = 0.09). The median AUCs of CLA and 14-hydroxyclarithromycin (14OH-CLA) were 2.9 mg x h/liter (IQR, 1.5 to 3.8 mg x h/liter) and 8.0 mg x h/liter (IQR, 6.7 to 8.6 mg x h/liter), respectively. The median concentration of CLA was above the MIC of M. ulcerans, but that of 14OH-CLA was not. In further clinical studies, a dose of CLA of 7.5 mg/kg twice daily should be used (or with an extended-release formulation, 15 mg/kg should be used) to ensure higher levels of exposure to CLA and an increase in the time above the MIC compared to those achieved with the currently used dose of 7.5 mg/kg once daily.
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