Intermittent Antimalaria Treatment With SP in African Children
Intermittent Treatment With Sulfadoxine-Pyrimethamine for Malaria Control in Children: A Randomised, Double Blind, and Placebo-Controlled Clinical Trial
2 other identifiers
interventional
1,200
0 countries
N/A
Brief Summary
\- intermittent preventive treatment with SP in children to evaluate efficacy and safety of this drug combination in children in northern Ghana
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Mar 2003
Typical duration for phase_4
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 15, 2005
CompletedNovember 2, 2005
February 1, 2003
September 13, 2005
November 1, 2005
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Efficacy and safety of IPTi with SP
Impact of IPTi on incidence on malaria attacks
Impact of IPTi on anemia
Secondary Outcomes (3)
Interaction between erythrocyte polymorphisms and SP
Influence on parasite multiplicity
Impact on child development
Interventions
Eligibility Criteria
You may qualify if:
- informed consent by parents or guardian
- no concomitant serious disease
- age \>2 months
You may not qualify if:
- serious allergy or hypersensitivity to sulfonamides or pyrimethamine
- no severe hepatic or renal dysfunction
- serious breach of study protocol
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (3)
Schellenberg D, Menendez C, Kahigwa E, Aponte J, Vidal J, Tanner M, Mshinda H, Alonso P. Intermittent treatment for malaria and anaemia control at time of routine vaccinations in Tanzanian infants: a randomised, placebo-controlled trial. Lancet. 2001 May 12;357(9267):1471-7. doi: 10.1016/S0140-6736(00)04643-2.
PMID: 11377597BACKGROUNDMenendez C, Kahigwa E, Hirt R, Vounatsou P, Aponte JJ, Font F, Acosta CJ, Schellenberg DM, Galindo CM, Kimario J, Urassa H, Brabin B, Smith TA, Kitua AY, Tanner M, Alonso PL. Randomised placebo-controlled trial of iron supplementation and malaria chemoprophylaxis for prevention of severe anaemia and malaria in Tanzanian infants. Lancet. 1997 Sep 20;350(9081):844-50. doi: 10.1016/S0140-6736(97)04229-3.
PMID: 9310602BACKGROUNDMassaga JJ, Kitua AY, Lemnge MM, Akida JA, Malle LN, Ronn AM, Theander TG, Bygbjerg IC. Effect of intermittent treatment with amodiaquine on anaemia and malarial fevers in infants in Tanzania: a randomised placebo-controlled trial. Lancet. 2003 May 31;361(9372):1853-60. doi: 10.1016/s0140-6736(03)13504-0.
PMID: 12788572BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Frank Mockenhaupt, PhD
Charite University-Medicine, Berlin, Germany
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 15, 2005
Study Start
March 1, 2003
Study Completion
August 1, 2005
Last Updated
November 2, 2005
Record last verified: 2003-02