Evidence map›Paper›PMID 27287644›Full record

Trial reportThe international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease2016

Bioavailability of two licensed paediatric rifampicin suspensions: implications for quality control programmes.

H McIlleron, H Hundt, W Smythe, A Bekker, J Winckler, L van der Laan, P Smith, H J Zar, A C Hesseling, G Maartens and 2 more

Abstract readClinical TrialComparative Study
In one paragraph

Trial report in The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 2 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

18 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Quality assurance of rifampicin-containing fixed-drug combinations in South Africa: dosing implications.The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease · 2018
    Trial
  6. Trial
  7. Article
  8. Review
  9. Pharmacokinetics and Safety of Twice-daily Ritonavir-boosted Atazanavir With Rifampicin.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2024
    Article
  10. Article
  11. Article
  12. Article
  13. Article
  14. Pharmacokinetics of First-Line Drugs Among Children With Tuberculosis in Rural Tanzania.Journal of the Pediatric Infectious Diseases Society · 2020
    Article
  15. Article
  16. Review
  17. NoninvasiveScience translational medicine · 2018
    Article
  18. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

H McIlleronDivision of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa.
H HundtDivision of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa.
W SmytheDivision of Clinical Pharmacology, Department of Medicine, Clinical Research Centre, Health Sciences Faculty, University of Cape Town, Cape Town, South Africa.
A BekkerDesmond Tutu TB Centre, Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa.
J WincklerDepartment of Paediatrics and Child Health, and Medical Research Council Unit on Child and Adolescent Health, University of Cape Town, Cape Town, South Africa.
L van der LaanDesmond Tutu TB Centre, Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa.
P SmithDivision of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa.
H J ZarDepartment of Paediatrics and Child Health, and Medical Research Council Unit on Child and Adolescent Health, University of Cape Town, Cape Town, South Africa; Red Cross War Memorial Children's Hospital, Cape Town, South Africa.
A C HesselingDesmond Tutu TB Centre, Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa.
G MaartensDivision of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa.
L WiesnerDivision of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa.
A van RieDepartment of Epidemiology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA; International Health Unit, Epidemiology and Social Medicine, Faculty of Medicine, University of Antwerp, Antwerp, Belgium.

Funding

Leadership and Operations Center (LOC), AIDS Clinical Trials Group (ACTG); LOC 1/UM1AI068636 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI Joseph J Eron, RAJESH T GANDHI · 2011 to 2026
$1073.1M
LOC-IMPAACT Leadership GroupPharmacokinetics and Safety of Remdesivir for Treatment of COVID-19 in Pregnant Women in the USUM1AI068632 · NIAID · SOCIAL AND SCIENTIFIC SYSTEMS, INC. · PI Jennifer Jao, Sharon A Nachman · 2011 to 2026
$278.1M
Statistical and Data Management Center (SDMC), AIDS Clinical Trials Group (ACTG)UM1AI068634 · NIAID · HARVARD UNIVERSITY D/B/A HARVARD SCHOOL OF PUBLIC HEALTH · PI Marlene Ann Cooper, Michael David Hughes · 2011 to 2026
$246.6M
Validation, CLIA and Qualification (VQC): Enhancing the RS ratio as a tool for AIDS Clinical Trial Group (ACTG) tuberculosis trialsUM1AI106701 · NIAID · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI Grace M Aldrovandi · 2014 to 2026
$116.8M
International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) GroupU01AI068632 · NIAID · SOCIAL AND SCIENTIFIC SYSTEMS, INC. · PI JACKSON, J BROOKS · 2006 to 2010
$109.7M
Optimal dosing of 1st line antituberculosis and antiretroviral drugs in childrenR01HD069175 · NICHD · UNIVERSITY OF CAPE TOWN · PI MCILLERON, HELEN · 2011 to 2018
$1.8M
NIAID NIH HHS U01 AI068632NIAID NIH HHS UM1 AI068632NIAID NIH HHS UM1 AI068634NIAID NIH HHS UM1 AI068636NIAID NIH HHS UM1 AI106701NICHD NIH HHS R01 HD069175
6 · The paper itself

Abstract

settingTo assess the revised World Health Organization-recommended dose of 10-20 mg/kg rifampicin (RMP), we studied the steady state pharmacokinetics of RMP in South African children who received standard treatment for drug-susceptible tuberculosis (TB).

objectiveTo determine the formulation effect on the pharmacokinetics of RMP.

designRMP plasma concentrations were characterised in 146 children (median age 1.4 years, range 0.2-10.2). The morning dose on the day of the pharmacokinetic evaluation was administered as one of two RMP single-drug oral suspensions.

resultsWhile one formulation achieved 2 h concentrations in the range of those observed in adults (median 6.54 mg/l, interquartile range [IQR] 4.47-8.84), the other attained a median bioavailability of only 25% of this, with a median 2 h concentration of 1.59 mg/l (IQR 0.89-2.38).

conclusionRMP is a key drug for the treatment of TB. It is critical that the quality of RMP suspensions used to treat childhood TB is ensured.

Indexed as

Drug ApprovalLicensureAdministration, OralAntibiotics, AntitubercularBiological AvailabilityChildChild, PreschoolDrug CompoundingDrug MonitoringFemaleHumansInfantMalePharmaceutical SolutionsQuality Assurance, Health CareQuality ControlAntibiotics, AntitubercularPharmaceutical SolutionsRifampin

Identifiers

PMID27287644
PMCPMC4978631

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.