Intermittent Antimalaria Treatment With SP in African Children

Anemia Clinical Trial

Official title:

Intermittent Treatment With Sulfadoxine-Pyrimethamine for Malaria Control in Children: A Randomised, Double Blind, and Placebo-Controlled Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00168948
• Other study ID #: 01KA0202-T
• Secondary ID: 01KA0202
• Status: Active, not recruiting
• Phase: Phase 4
• First received: September 13, 2005
• Last updated: November 1, 2005
• Start date: March 2003
• Est. completion date: August 2005

Study information

• Verified date: February 2003
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ghana: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1200
• Est. completion date: August 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 2 Months to 4 Months

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Anemia
• Malaria

Intervention

Drug:
• Sulfadoxin (12.5) Pyrimethamine (250 mg)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	Deutscher Akademischer Austausch Dienst

References & Publications (3)

Massaga JJ, Kitua AY, Lemnge MM, Akida JA, Malle LN, Rønn 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy and safety of IPTi with SP
Primary	Impact of IPTi on incidence on malaria attacks
Primary	Impact of IPTi on anemia
Secondary	Interaction between erythrocyte polymorphisms and SP
Secondary	Influence on parasite multiplicity
Secondary	Impact on child development

External Links

•   Click here for more information about this study