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Intermittent Antimalaria Treatment With SP in African Children

NCT ID: NCT00168948

Last Updated: 2005-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

1200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-03-31

Study Completion Date

2005-08-31

Brief Summary

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

Detailed Description

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* 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

Conditions

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Malaria Anemia

Keywords

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Intermittent preventive treatment IPTi Malaria control Ghana

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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Sulfadoxin (12.5) Pyrimethamine (250 mg)

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

2 Months

Maximum Eligible Age

4 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Deutscher Akademischer Austausch Dienst

OTHER

Sponsor Role collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Principal Investigators

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Frank Mockenhaupt, PhD

Role: STUDY_DIRECTOR

Charite University-Medicine, Berlin, Germany

References

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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.

Reference Type BACKGROUND
PMID: 11377597 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9310602 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12788572 (View on PubMed)

Other Identifiers

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01KA0202

Identifier Type: -

Identifier Source: secondary_id

01KA0202-T

Identifier Type: -

Identifier Source: org_study_id