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Intermittent Antimalaria Treatment With SP in African Children

Primary Purpose

Malaria, Anemia

Status

Unknown status

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Sulfadoxin (12.5) Pyrimethamine (250 mg)

About this trial

This is an interventional prevention trial for Malaria focused on measuring Intermittent preventive treatment, IPTi, Malaria control, Ghana

Eligibility Criteria

2 Months - 4 Months (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Outcomes

Primary Outcome Measures

Efficacy and safety of IPTi with SP

Impact of IPTi on incidence on malaria attacks

Impact of IPTi on anemia

Secondary Outcome Measures

Interaction between erythrocyte polymorphisms and SP

Influence on parasite multiplicity

Impact on child development

Full Information

NCT ID

NCT00168948

First Posted

September 13, 2005

Last Updated

November 1, 2005

Sponsor

Charite University, Berlin, Germany

Collaborators

Deutscher Akademischer Austausch Dienst

1. Study Identification

Unique Protocol Identification Number

NCT00168948

Brief Title

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

2. Study Status

Record Verification Date

February 2003

Overall Recruitment Status

Unknown status

Study Start Date

March 2003 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

August 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Charite University, Berlin, Germany

Collaborators

Deutscher Akademischer Austausch Dienst

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Malaria, Anemia

Keywords

Intermittent preventive treatment, IPTi, Malaria control, Ghana

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

1200 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Sulfadoxin (12.5) Pyrimethamine (250 mg)

Primary Outcome Measure Information:

Title

Efficacy and safety of IPTi with SP

Title

Impact of IPTi on incidence on malaria attacks

Title

Impact of IPTi on anemia

Secondary Outcome Measure Information:

Title

Interaction between erythrocyte polymorphisms and SP

Title

Influence on parasite multiplicity

Title

Impact on child development

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Months

Maximum Age & Unit of Time

4 Months

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Frank Mockenhaupt, PhD

Organizational Affiliation

Charite University-Medicine, Berlin, Germany

Official's Role

Study Director

12. IPD Sharing Statement

Citations:

PubMed Identifier

11377597

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.

Results Reference

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PubMed Identifier

9310602

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.

Results Reference

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PubMed Identifier

12788572

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.

Results Reference

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Intermittent Antimalaria Treatment With SP in African Children

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