Evidence map›Paper›PMID 25362206›Full record

ArticleClinical infectious diseases : an official publication of the Infectious Diseases Society of America2015

Pharmacokinetics and safety of moxifloxacin in children with multidrug-resistant tuberculosis.

Stephanie Thee, Anthony J Garcia-Prats, Heather R Draper, Helen M McIlleron, Lubbe Wiesner, Sandra Castel, H Simon Schaaf, Anneke C Hesseling

Open access · bronzeAbstract read
In one paragraph

Article in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 40 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
40citing papers in PubMed, 3 pooled it
8.9field-weighted citation impact, top 2% of its field
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

40 citing papers in PubMed, 3 syntheses or guidelines pooled it, 71 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Treatment of Drug-Resistant Tuberculosis. An Official ATS/CDC/ERS/IDSA Clinical Practice Guideline.American journal of respiratory and critical care medicine · 2019
    Guideline
  4. Trial
  5. Trial
  6. Article
  7. Article
  8. Pharmacology of emerging drugs for the treatment of multi-drug resistant tuberculosis.Journal of clinical tuberculosis and other mycobacterial diseases · 2024
    Review
  9. Article
  10. Review
  11. Article
  12. Safety of Antimicrobials for Postexposure Prophylaxis and Treatment of Anthrax: A Review.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2022
    Review
  13. Moxifloxacin Pharmacokinetics, Cardiac Safety, and Dosing for the Treatment of Rifampicin-Resistant Tuberculosis in Children.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2022
    Article
  14. Review
  15. Article
  16. Global sales of oral antibiotics formulated for children.Bulletin of the World Health Organization · 2020
    Article
  17. Review
  18. [Clofazimine suspension formulation for treating extremely resistant tuberculosis in a nursing patient].Revista espanola de quimioterapia : publicacion oficial de la Sociedad Espanola de Quimioterapia · 2019
    Article
  19. Effect of tablet crushing on drug exposure in the treatment of multidrug-resistant tuberculosis.The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease · 2019
    Article
  20. Pharmacokinetics of Second-Line Anti-Tubercular Drugs.Indian journal of pediatrics · 2019
    Review
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

8 authors at 4 institutions in 2 countries.

Stephanie TheeDesmond Tutu Tuberculosis Centre, Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, South Africa Department of Paediatric Pneumology and Immunology, Universitätsmedizin Berlin, Charité, Germany.
Anthony J Garcia-PratsDesmond Tutu Tuberculosis Centre, Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, South Africa.
Heather R DraperDesmond Tutu Tuberculosis Centre, Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, South Africa.
Helen M McIlleronDivision of Clinical Pharmacology, Department of Medicine, University of Cape Town, South Africa.
Lubbe WiesnerDivision of Clinical Pharmacology, Department of Medicine, University of Cape Town, South Africa.
Sandra CastelDivision of Clinical Pharmacology, Department of Medicine, University of Cape Town, South Africa.
H Simon SchaafDesmond Tutu Tuberculosis Centre, Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, South Africa.
Anneke C HesselingDesmond Tutu Tuberculosis Centre, Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, South Africa.
University of Cape Town · ZADesmond Tutu HIV Foundation · ZAStellenbosch University · ZACharité - Universitätsmedizin Berlin · DE

Funding

PHARMACOKINETICS AND TOXICITY OF SECONDLINE ANTITUBERCULOSIS DRUGS IN HIV-INFECTER01HD069169 · NICHD · STELLENBOSCH UNIVERSITY · PI HESSELING, ANNEKE CATHARINA · 2011 to 2015
$2.0M
NICHD NIH HHS R01 HD069169PHS HHS R01 069169-01
6 · The paper itself

Abstract

backgroundMoxifloxacin is currently recommended at a dose of 7.5-10 mg/kg for children with multidrug-resistant (MDR) tuberculosis, but pharmacokinetic and long-term safety data of moxifloxacin in children with tuberculosis are lacking. An area under the curve (AUC) of 40-60 µg × h/mL following an oral moxifloxacin dose of 400 mg has been reported in adults.

methodsIn a prospective pharmacokinetic and safety study, children 7-15 years of age routinely receiving moxifloxacin 10 mg/kg daily as part of multidrug treatment for MDR tuberculosis in Cape Town, South Africa, for at least 2 weeks, underwent intensive pharmacokinetic sampling (predose and 1, 2, 4, 8, and either 6 or 11 hours) and were followed for safety. Assays were performed using liquid chromatography-tandem mass spectrometry, and pharmacokinetic measures calculated using noncompartmental analysis.

resultsTwenty-three children were included (median age, 11.1 years; interquartile range [IQR], 9.2-12.0 years); 6 of 23 (26.1%) were human immunodeficiency virus (HIV)-infected. The median maximum serum concentration (Cmax), area under the curve from 0-8 hours (AUC0-8), time until Cmax (Tmax), and half-life for moxifloxacin were 3.08 (IQR, 2.85-3.82) µg/mL, 17.24 (IQR, 14.47-21.99) µg × h/mL, 2.0 (IQR, 1.0-8.0) h, and 4.14 (IQR, 3.45-6.11), respectively. Three children, all HIV-infected, were underweight for age. AUC0-8 was reduced by 6.85 µg × h/mL (95% confidence interval, -11.15 to -2.56) in HIV-infected children. Tmax was shorter with crushed vs whole tablets (P = .047). Except in 1 child with hepatotoxicity, all adverse effects were mild and nonpersistent. Mean corrected QT interval was 403 (standard deviation, 30) ms, and no prolongation >450 ms occurred.

conclusionsChildren 7-15 years of age receiving moxifloxacin 10 mg/kg/day as part of MDR tuberculosis treatment have low serum concentrations compared with adults receiving 400 mg moxifloxacin daily. Higher moxifloxacin dosages may be required in children. Moxifloxacin was well tolerated in children treated for MDR tuberculosis.

Indexed as

AdolescentAntibiotics, AntitubercularArea Under CurveChildDrug ToleranceFemaleFluoroquinolonesHalf-LifeHIV InfectionsHumansMaleMoxifloxacinProspective StudiesSouth AfricaTuberculosis, Multidrug-ResistantAntibiotics, AntitubercularFluoroquinolonesMoxifloxacinchildrenMDR tuberculosismoxifloxacin pharmacokineticsmoxifloxacin toxicity

Identifiers

PMID25362206
PMCPMC4366580
OpenAlexW2169788739

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.