Clinical trial NCT00168948: Intermittent Antimalaria Treatment With SP in African Children
Official title: Intermittent Treatment With Sulfadoxine-Pyrimethamine for Malaria Control in Children: A Randomised, Double Blind, and Placebo-Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Malaria
Anemia
Keywords: Intermittent preventive treatment
IPTi
Malaria control
Ghana
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: Deutscher Akademischer Austausch Dienst
First posted: 2005-09-15
Enrollment: 1200
Sex: ALL
Minimum age (years): 2
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: - intermittent preventive treatment with SP in children to evaluate efficacy and safety of this drug combination in children in northern Ghana

Detailed description: * Sulfadoxine and pyrimethamine have long been used for malaria prevention and treatment. In this study, following suggestions of WHO, these drugs are used for intermittent treatment.
* It will be tested if this approach reduces the number of malaria attacks and ameliorates the severity of the disease
* It will also be determined if anemia due to malaria, which is prevalent in northern Ghana, may be reduced
* Moreover, the interaction between red cell polymorphisms such as HbS, HbC, alpha-thalassemia and glucose-6-phosphate dehydrogenase deficiency and SP will be examined

Eligibility criteria: Inclusion Criteria:

* informed consent by parents or guardian
* no concomitant serious disease
* age \>2 months

Exclusion Criteria:

* serious allergy or hypersensitivity to sulfonamides or pyrimethamine
* no severe hepatic or renal dysfunction
* serious breach of study protocol

Primary outcomes:
measure: Efficacy and safety of IPTi with SP
measure: Impact of IPTi on incidence on malaria attacks
measure: Impact of IPTi on anemia
Secondary outcomes:
measure: Interaction between erythrocyte polymorphisms and SP
measure: Influence on parasite multiplicity
measure: Impact on child development
Other outcomes:
Locations:
Study officials:
affiliation: Charite University-Medicine, Berlin, Germany
name: Frank Mockenhaupt, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Menendez 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.
citation: Massaga 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.