Evidence map›Paper›PMID 35404075›Full record

Trial reportAntimicrobial agents and chemotherapy2022

Delamanid Added to an Optimized Background Regimen in Children with Multidrug-Resistant Tuberculosis: Results of a Phase I/II Clinical Trial.

Anthony J Garcia-Prats, Melchior Frias, Louvina van der Laan, Anjanette De Leon, Maria Tarcela Gler, H Simon Schaaf, Anneke C Hesseling, Suresh Malikaarjun, Jeffrey Hafkin

Open access · hybridAbstract readClinical Trial, Phase IClinical Trial, Phase II
In one paragraph

Trial report in Antimicrobial agents and chemotherapy, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 2 pooled it
1.9field-weighted citation impact, top 13% 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

8 citing papers in PubMed, 2 syntheses or guidelines pooled it, 19 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Review
  4. Article
  5. Review
  6. Article
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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

9 authors at 4 institutions in 3 countries.

Anthony J Garcia-PratsDesmond Tutu TB Centre, Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch Universitygrid.11956.3a, Cape Town, South Africa.ORCID 0000-0002-9280-1950
Melchior FriasDe La Salle Health Science Center, Cavite, Philippines.
Louvina van der LaanDesmond Tutu TB Centre, Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch Universitygrid.11956.3a, Cape Town, South Africa.
Anjanette De LeonLung Center of the Philippines, Quezon City, Philippines.
Maria Tarcela GlerDe La Salle Health Science Center, Cavite, Philippines.
H Simon SchaafDesmond Tutu TB Centre, Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch Universitygrid.11956.3a, Cape Town, South Africa.
Anneke C HesselingDesmond Tutu TB Centre, Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch Universitygrid.11956.3a, Cape Town, South Africa.
Suresh MalikaarjunOtsuka Pharmaceutical Development & Commercialization, Rockville, Maryland, USA.
Jeffrey HafkinOtsuka Pharmaceutical Development & Commercialization, Rockville, Maryland, USA.ORCID 0000-0002-6690-3240
Desmond Tutu HIV Foundation · ZADe La Salle University · PHPharmaceutical Product Development (United States) · USLung Center of the Philippines · PH

Funding

Emory HIV/AIDS Clinical Trials UnitUM1AI069418 · NIAID · EMORY UNIVERSITY · PI Colleen F Kelley · 2012 to 2026
$46.0M
Neuro HPA Project 1U54AG062334 · NIA · EMORY UNIVERSITY · PI Ighovwerha Ofotokun · 2018 to 2026
$12.2M
NIAID NIH HHS UM1 AI069418NIA NIH HHS U54 AG062334
6 · The paper itself

Abstract

Delamanid has been demonstrated to be safe and effective for treatment of adult multidrug-resistant tuberculosis (MDR-TB) and has been approved by the European Commission for treatment of pediatric MDR-TB patients at least 10 kg in weight, making the drug no longer limited to adults. A 10-day phase I age deescalation study was conducted, followed by a 6-month phase II extension study, to assess the pharmacokinetics, safety, tolerability, and preliminary efficacy of delamanid when combined with optimized background regimen (OBR) in children (birth to 17 years) with MDR-TB. Delamanid administered at 100 mg twice-daily (BID), 50 mg BID, and 25 mg BID resulted in exposures in 12- to 17- (

Indexed as

NitroimidazolesTuberculosis, Multidrug-ResistantAdultAntitubercular AgentsChildChild, PreschoolFemaleHumansOxazolesTreatment OutcomeAntitubercular AgentsNitroimidazolesOPC-67683Oxazolesage deescalation studydelamanidefficacymultidrug-resistant tuberculosispediatric tuberculosispharmacokineticssafety

Identifiers

PMID35404075
PMCPMC9112969
OpenAlexW4223468350

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.