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NCT01722539: PIP-IPT

Efficacy and Safety of Sulfadoxine-pyrimethamine or Sulfadoxine-pyrimethamine Plus Piperaquine Regimens Delivered Through Intermittent Preventive Treatment in Schoolchildren of Democratic Republic of Congo: A Randomised Control Trial

Completed Phase 3 Last updated 3 February 2014
What this trial tests

Phase 3 trial testing Sulfadoxine-pyrimethamine in Healthy in 616 participants. Completed in 1 November 2013.

Timeline
1 November 2012
Primary endpoint
1 November 2013
1 November 2013

Quick facts

Lead sponsorUniversiteit Antwerpen
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposeprevention
Enrollment616
Start date1 November 2012
Primary completion1 November 2013
Estimated completion1 November 2013
Sites1 location across Republic of the Congo

Drugs / interventions tested

Conditions studied

Sponsor

Universiteit Antwerpen — full company profile →

Who can join

Adults 5 to 14, any sex, with Healthy. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Sponsor's own description

Considering the facts that: (i) IPT of malaria provides substantial protection against anaemia and malaria in school children (ii); SP resistance has no significant impact on the prophylactic efficacy (iii) SP-PQ is safe and as efficacious as SP: the investigators hypothesize that antimalarial IPT with SP and SP-PQ will improve haemoglobin concentration, reduce anaemia prevalence, malaria incidence and parasitaemia, and improve malnutrition and school performance in school-aged children of Congo.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Malaria, schistosomiasis and soil transmitted helminth burden and their correlation with anemia in children attending primary schools in Kinshasa, Democratic Republic of Congo.
    Matangila JR, Doua JY, Linsuke S, Madinga J, et al · · 2014 · cited 39× · PMID 25372029 · DOI 10.1371/journal.pone.0110789
  2. Intermittent preventive treatment: efficacy and safety of sulfadoxine-pyrimethamine and sulfadoxine-pyrimethamine plus piperaquine regimens in schoolchildren of the Democratic Republic of Congo: a study protocol for a randomized controlled trial.
    Doua JY, Matangila J, Lutumba P, Van Geertruyden JP. · · 2013 · cited 10× · PMID 24063608 · DOI 10.1186/1745-6215-14-311
  3. Poster Sessions
    · 2015

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Other trials of Sulfadoxine-pyrimethamine

Trials testing the same drug.

Other recruiting trials for Healthy

Currently open trials in the same condition.

Other Universiteit Antwerpen trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01722539.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing