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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
Phase 3 trial testing Sulfadoxine-pyrimethamine in Healthy in 616 participants. Completed in 1 November 2013.
1 November 2013
Quick facts
| Lead sponsor | Universiteit Antwerpen |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 616 |
| Start date | 1 November 2012 |
| Primary completion | 1 November 2013 |
| Estimated completion | 1 November 2013 |
| Sites | 1 location across Republic of the Congo |
Drugs / interventions tested
- Sulfadoxine-pyrimethamine
- Piperaquine — full drug profile →
- Albendazole (ALBENDAZOLE) — full drug profile →
- Praziquantel — full drug profile →
Conditions studied
- Healthy — all drugs for Healthy →
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.
-
Hemoglobin change
Time frame: Month 0-Month 12
Change in mean Hb concentration at month 12 of follow-up and anaemia prevalence one year after initial preventive treatment;
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):
-
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 -
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 -
Poster Sessions
· 2015
Verify or expand the search:
- PubMed search for NCT01722539
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Sulfadoxine-pyrimethamine
Trials testing the same drug.
- NCT03009526 — Efficacy and Safety of IPTp-DP Versus IPTp-SP in Malawi · Phase 3 · completed
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Other Universiteit Antwerpen trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01722539 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Universiteit Antwerpen
- Last refreshed: 3 February 2014
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