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Pharmacokinetics and safety of high-dose rifampicin in children with TB : the Opti-Rif trial

Garcia-Prats, Anthony J. (författare)
Stellenbosch Univ, Fac Med & Hlth Sci, Desmond Tutu TB Ctr, Dept Paediat & Child Hlth, POB 241, ZA-8000 Cape Town, South Africa.;Univ Wisconsin, Dept Pediat, Sch Med & Publ Hlth, 2870 Univ Ave,Suite 200, Madison, WI 53705 USA.
Svensson, Elin, 1985- (författare)
Uppsala universitet,Institutionen för farmaci,Radboud Univ Nijmegen Med Ctr, Radboud Inst Hlth Sci, Dept Pharm, POB 9101, NL-6500 HB Nijmegen, Netherlands.
Winckler, Jana (författare)
Stellenbosch Univ, Fac Med & Hlth Sci, Desmond Tutu TB Ctr, Dept Paediat & Child Hlth, POB 241, ZA-8000 Cape Town, South Africa.
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Draper, Heather R. (författare)
Stellenbosch Univ, Fac Med & Hlth Sci, Desmond Tutu TB Ctr, Dept Paediat & Child Hlth, POB 241, ZA-8000 Cape Town, South Africa.
Fairlie, Lee (författare)
Univ Witwatersrand, Fac Hlth Sci, Wits Reprod Hlth & HIV Inst Shandukani CRS, 22 Esselen St, ZA-2001 Hilbrow, South Africa.
van der Laan, Louvina E. (författare)
Stellenbosch Univ, Fac Med & Hlth Sci, Desmond Tutu TB Ctr, Dept Paediat & Child Hlth, POB 241, ZA-8000 Cape Town, South Africa.
Masenya, Masebole (författare)
Univ Witwatersrand, Fac Hlth Sci, Wits Reprod Hlth & HIV Inst Shandukani CRS, 22 Esselen St, ZA-2001 Hilbrow, South Africa.
Schaaf, H. Simon (författare)
Stellenbosch Univ, Fac Med & Hlth Sci, Desmond Tutu TB Ctr, Dept Paediat & Child Hlth, POB 241, ZA-8000 Cape Town, South Africa.
Wiesner, Lubbe (författare)
Univ Cape Town, Groote Schuur Hosp, Dept Med, Div Clin Pharmacol, K45 Old Main Bldg, ZA-7925 Cape Town, South Africa.
Norman, Jennifer (författare)
Univ Cape Town, Groote Schuur Hosp, Dept Med, Div Clin Pharmacol, K45 Old Main Bldg, ZA-7925 Cape Town, South Africa.
Aarnoutse, Rob E. (författare)
Radboud Univ Nijmegen Med Ctr, Radboud Inst Hlth Sci, Dept Pharm, POB 9101, NL-6500 HB Nijmegen, Netherlands.
Karlsson, Mats O. (författare)
Uppsala universitet,Institutionen för farmaci
Denti, Paolo (författare)
Univ Cape Town, Groote Schuur Hosp, Dept Med, Div Clin Pharmacol, K45 Old Main Bldg, ZA-7925 Cape Town, South Africa.
Hesseling, Anneke C. (författare)
Stellenbosch Univ, Fac Med & Hlth Sci, Desmond Tutu TB Ctr, Dept Paediat & Child Hlth, POB 241, ZA-8000 Cape Town, South Africa.
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Stellenbosch Univ, Fac Med & Hlth Sci, Desmond Tutu TB Ctr, Dept Paediat & Child Hlth, POB 241, ZA-8000 Cape Town, South Africa;Univ Wisconsin, Dept Pediat, Sch Med & Publ Hlth, 2870 Univ Ave,Suite 200, Madison, WI 53705 USA. Institutionen för farmaci (creator_code:org_t)
2021-09-16
2021
Engelska.
Ingår i: Journal of Antimicrobial Chemotherapy. - : Oxford University Press. - 0305-7453 .- 1460-2091. ; 76:12, s. 3237-3246
Relaterad länk:
https://urn.kb.se/re...
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https://doi.org/10.1...
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  • Tidskriftsartikel (refereegranskat)
Abstract Ämnesord
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  • Background: Rifampicin doses of 40 mg/kg in adults are safe and well tolerated, may shorten anti-TB treatment and improve outcomes, but have not been evaluated in children. Objectives: To characterize the pharmacokinetics and safety of high rifampicin doses in children with drug-susceptible TB. Patients and methods: The Opti-Rif trial enrolled dosing cohorts of 20 children aged 0-12 years, with incremental dose escalation with each subsequent cohort, until achievement of target exposures or safety concerns. Cohort 1 opened with a rifampicin dose of 15 mg/kg for 14 days, with a single higher dose (35 mg/kg) on day 15. Pharmacokinetic data from days 14 and 15 were analysed using population modelling and safety data reviewed. Incrementally increased rifampicin doses for the next cohort (days 1-14 and day 15) were simulated from the updated model, up to the dose expected to achieve the target exposure [235 mg/L.h, the geometric mean area under the concentration-time curve from 0 to 24h (AUC(0-24)) among adults receiving a 35mg/kg dose]. Results: Sixty-two children were enrolled in three cohorts. The median age overall was 2.1 years (range=0.4-11.7). Evaluated doses were similar to 35 mg/kg (days 1-14) and similar to 50 mg/kg (day 15) for cohort 2 and similar to 60 mg/kg (days 1-14) and similar to 75mg/kg (day 15) for cohort 3. Approximately half of participants had an adverse event related to study rifampicin; none was grade 3 or higher. A 65-70 mg/kg rifampicin dose was needed in children to reach the target exposure. Conclusions: High rifampicin doses in children achieved target exposures and the doses evaluated were safe over 2 weeks.

Ämnesord

MEDICIN OCH HÄLSOVETENSKAP  -- Medicinska och farmaceutiska grundvetenskaper -- Farmaceutiska vetenskaper (hsv//swe)
MEDICAL AND HEALTH SCIENCES  -- Basic Medicine -- Pharmaceutical Sciences (hsv//eng)
MEDICIN OCH HÄLSOVETENSKAP  -- Medicinska och farmaceutiska grundvetenskaper -- Farmakologi och toxikologi (hsv//swe)
MEDICAL AND HEALTH SCIENCES  -- Basic Medicine -- Pharmacology and Toxicology (hsv//eng)

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