Intermittent Antimalaria Treatment With SP in African Children

The recruitment status of this study is unknown because the information has not been verified recently.

Verified February 2003 by Charite University, Berlin, Germany.
Recruitment status was Active, not recruiting

Sponsor:

Collaborator:

Deutscher Akademischer Austausch Dienst

Information provided by:

Charite University, Berlin, Germany

ClinicalTrials.gov Identifier:

NCT00168948

First received: September 13, 2005

Last updated: November 1, 2005

Last verified: February 2003

History of Changes

Tracking Information

First Received Date ^ICMJE

September 13, 2005

Last Updated Date

November 1, 2005

Start Date ^ICMJE

March 2003

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Efficacy and safety of IPTi with SP
Impact of IPTi on incidence on malaria attacks
Impact of IPTi on anemia

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00168948 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Interaction between erythrocyte polymorphisms and SP
Influence on parasite multiplicity
Impact on child development

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Intermittent Antimalaria Treatment With SP in African Children

Official Title ^ICMJE

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

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

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

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

Condition ^ICMJE

Malaria
Anemia

Intervention ^ICMJE

Drug: Sulfadoxin (12.5) Pyrimethamine (250 mg)

Study Arm (s)

Not Provided

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

1200

Completion Date

August 2005

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

2 Months to 4 Months

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00168948

Other Study ID Numbers ^ICMJE

01KA0202-T, 01KA0202

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Charite University, Berlin, Germany

Collaborators ^ICMJE

Deutscher Akademischer Austausch Dienst

Investigators ^ICMJE

Study Director:

Frank Mockenhaupt, PhD

Charite University-Medicine, Berlin, Germany

Information Provided By

Charite University, Berlin, Germany

Verification Date

February 2003

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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