Intermittent Antimalaria Treatment With SP in African Chi... | NCT00168948

Studies
Intermittent Antimalaria Treatment With SP in African Children

NCT00168948

Sponsor

Charite University, Berlin, Germany

Status

Unknown status

Last Update Posted

Nov 2, 2005Estimated

Enrollment

1,200

Phase

Phase 4

Conditions

Malaria
Anemia

Interventions

Sulfadoxin (12.5) Pyrimethamine (250 mg)

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
01KA0202

Status Module

Record Verification Date

Feb 2003

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2003

Primary Completion Date

Not provided

Completion Date

Aug 2005

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 15, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 1, 2005

Last Update Posted Date

Nov 2, 2005Estimated

Name	Class
Deutscher Akademischer Austausch Dienst	OTHER

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,200

Name	Type	Description	Arm Group Labels	Other Names
Sulfadoxin (12.5) Pyrimethamine (250 mg)	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Efficacy and safety of IPTi with SP
Impact of IPTi on incidence on malaria attacks
Impact of IPTi on anemia

Secondary Outcomes

Measure	Description	Time Frame
Interaction between erythrocyte polymorphisms and SP
Influence on parasite multiplicity
Impact on child development

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Months

Maximum Age

4 Months

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Frank Mockenhaupt, PhD	Charite University-Medicine, Berlin, Germany	Study Director

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
11377597	Background	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.
9310602	Background

ID	Term
D011528	Protozoan Infections
D010272	Parasitic Diseases
D007239	Infections
D000096724	Mosquito-Borne Diseases

ID	Term
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

ID	Term
D008288	Malaria
D000740	Anemia