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Pharmacokinetics an...
Pharmacokinetics and safety of high-dose rifampicin in children with TB : the Opti-Rif trial
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- 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.
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- 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.
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- 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.
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- Fairlie, Lee (författare)
- Univ Witwatersrand, Fac Hlth Sci, Wits Reprod Hlth & HIV Inst Shandukani CRS, 22 Esselen St, ZA-2001 Hilbrow, South Africa.
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- 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.
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- Masenya, Masebole (författare)
- Univ Witwatersrand, Fac Hlth Sci, Wits Reprod Hlth & HIV Inst Shandukani CRS, 22 Esselen St, ZA-2001 Hilbrow, South Africa.
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- 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.
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- Wiesner, Lubbe (författare)
- Univ Cape Town, Groote Schuur Hosp, Dept Med, Div Clin Pharmacol, K45 Old Main Bldg, ZA-7925 Cape Town, South Africa.
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- Norman, Jennifer (författare)
- Univ Cape Town, Groote Schuur Hosp, Dept Med, Div Clin Pharmacol, K45 Old Main Bldg, ZA-7925 Cape Town, South Africa.
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- Aarnoutse, Rob E. (författare)
- Radboud Univ Nijmegen Med Ctr, Radboud Inst Hlth Sci, Dept Pharm, POB 9101, NL-6500 HB Nijmegen, Netherlands.
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- Karlsson, Mats O. (författare)
- Uppsala universitet,Institutionen för farmaci
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- Denti, Paolo (författare)
- Univ Cape Town, Groote Schuur Hosp, Dept Med, Div Clin Pharmacol, K45 Old Main Bldg, ZA-7925 Cape Town, South Africa.
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- 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.
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Ingår i: Journal of Antimicrobial Chemotherapy. - : Oxford University Press. - 0305-7453 .- 1460-2091. ; 76:12, s. 3237-3246
- 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
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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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Garcia-Prats, An ...
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Svensson, Elin, ...
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Winckler, Jana
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Draper, Heather ...
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Fairlie, Lee
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van der Laan, Lo ...
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Masenya, Masebol ...
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Schaaf, H. Simon
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Wiesner, Lubbe
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Norman, Jennifer
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Aarnoutse, Rob E ...
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Karlsson, Mats O ...
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Denti, Paolo
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Hesseling, Annek ...
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