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Early Bactericidal ...
Early Bactericidal Activity of Meropenem plus Clavulanate (with or without Rifampin) for Tuberculosis : The COMRADE Randomized, Phase 2A Clinical Trial
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- De Jager, Veronique (författare)
- TASK Appl Sci, Cape Town, South Africa.
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- Gupte, Nikhil (författare)
- Johns Hopkins Univ, Sch Med, Dept Med, Baltimore, MD 21287 USA.;Johns Hopkins India, Pune, Maharashtra, India.
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- Nunes, Silvia (författare)
- TASK Appl Sci, Cape Town, South Africa.
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- Barnes, Grace L. (författare)
- Johns Hopkins Univ, Sch Med, Dept Med, Baltimore, MD 21287 USA.
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- Van Wijk, Rob C, 1991- (författare)
- Uppsala universitet,Institutionen för farmaceutisk biovetenskap
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- Mostert, Joni (författare)
- TASK Appl Sci, Cape Town, South Africa.
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- Dorman, Susan E. (författare)
- Med Univ South Carolina, Charleston, SC 29425 USA.
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- Abulfathi, Ahmed A. (författare)
- Stellenbosch Univ, Dept Med, Cape Town, South Africa.;Univ Maiduguri, Dept Clin Pharmacol & Therapeut, Maiduguri, Nigeria.
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- Upton, Caryn M. (författare)
- TASK Appl Sci, Cape Town, South Africa.
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- Faraj, Alan (författare)
- Uppsala universitet,Institutionen för farmaceutisk biovetenskap
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- Nuermberger, Eric L. (författare)
- Johns Hopkins Univ, Sch Med, Dept Med, Baltimore, MD 21287 USA.
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- Lamichhane, Gyanu (författare)
- Johns Hopkins Univ, Sch Med, Dept Med, Baltimore, MD 21287 USA.
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- Svensson, Elin, 1985- (författare)
- Uppsala universitet,Institutionen för farmaci,Radboud Univ Nijmegen, Dept Pharm, Njimegen, Netherlands.
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- Simonsson, Ulrika S. H., Professor (författare)
- Uppsala universitet,Institutionen för farmaceutisk biovetenskap
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- Diacon, Andreas H. (författare)
- TASK Appl Sci, Cape Town, South Africa.
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- Dooley, Kelly E. (författare)
- Johns Hopkins Univ, Sch Med, Dept Med, Baltimore, MD 21287 USA.
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TASK Appl Sci, Cape Town, South Africa Johns Hopkins Univ, Sch Med, Dept Med, Baltimore, MD 21287 USA.;Johns Hopkins India, Pune, Maharashtra, India. (creator_code:org_t)
- American Thoracic Society, 2022
- 2022
- Engelska.
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Ingår i: American Journal of Respiratory and Critical Care Medicine. - : American Thoracic Society. - 1073-449X .- 1535-4970. ; 205:10, s. 1228-1235
- Relaterad länk:
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https://urn.kb.se/re...
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https://doi.org/10.1...
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Abstract
Ämnesord
Stäng
- Rationale: Carbapenems are recommended for treatment of drug-resistant tuberculosis. Optimal dosing remains uncertain.Objectives: To evaluate the 14-day bactericidal activity of meropenem, at different doses, with or without rifampin.Methods: Individuals with drug-sensitive pulmonary tuberculosis were randomized to one of four intravenous meropenem-based arms: 2 g every 8 hours (TID) (arm C), 2 g TID plus rifampin at 20 mg/kg once daily (arm D), 1 g TID (arm E), or 3 g once daily (arm F). All participants received amoxicillin/clavulanate with each meropenem dose. Serial overnight sputum samples were collected from baseline and throughout treatment. Median daily fall in colony-forming unit (CFU) counts per milliliter of sputum (solid culture) (EBA(CFU0-14)) and increase in time to positive culture (TTP) in liquid media were estimated with mixed-effects modeling. Serial blood samples were collected for pharmacokinetic analysis on Day 13.Measurements and Main Results: Sixty participants enrolled. Median EBA(CFU0-14) counts (2.5th-97.5th percentiles) were 0.22 (0.12-0.33), 0.12 (0.057-0.21), 0.059 (0.033-0.097), and 0.053 (0.035-0.081); TTP increased by 0.34 (0.21-0.75), 0.11 (0.052-037), 0.094 (0.034-0.23), and 0.12 (0.04-0.41) (log(10) h), for arms C-F, respectively. Meropenem pharmacokinetics were not affected by rifampin coadministration. Twelve participants withdrew early, many of whom cited gastrointestinal adverse events.Conclusions: Bactericidal activity was greater with the World Health Organization-recommended total daily dose of 6 g daily than with a lower dose of 3 g daily. This difference was only detectable with solid culture. Tolerability of intravenous meropenem, with amoxicillin/clavulanate, though, was poor at all doses, calling into question the utility of this drug in second-line regimens.
Ämnesord
- MEDICIN OCH HÄLSOVETENSKAP -- Medicinska och farmaceutiska grundvetenskaper -- Farmaceutiska vetenskaper (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Basic Medicine -- Pharmaceutical Sciences (hsv//eng)
Nyckelord
- tuberculosis
- carbapenem
- early bactericidal activity
- meropenem
- phase 2A clinical trial
Publikations- och innehållstyp
- ref (ämneskategori)
- art (ämneskategori)
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De Jager, Veroni ...
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Gupte, Nikhil
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Nunes, Silvia
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Barnes, Grace L.
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Van Wijk, Rob C, ...
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Mostert, Joni
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Dorman, Susan E.
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Abulfathi, Ahmed ...
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Upton, Caryn M.
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Faraj, Alan
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Nuermberger, Eri ...
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Lamichhane, Gyan ...
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Svensson, Elin, ...
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Simonsson, Ulrik ...
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Diacon, Andreas ...
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Dooley, Kelly E.
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