Efficacy of Sulphadoxine-pyrimethamine and Artemisinin-containing Combination Therapy for Malaria

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Primary Purpose

Status

Completed

Phase

Phase 4

Locations

Tanzania

Study Type

Interventional

Intervention

Sulfadoxine-pyrimethamine

sulfadoxine-pyrimethamine plus artesunate

lumefantrine plus artemether

Sleeping under insecticide-treated bednet

About this trial

This is an interventional treatment trial for Malaria (Uncomplicated) focused on measuring malaria, sulfadoxine-pyrimethamine, sulfadoxine-pyrimethamine plus artsunate, lumefantrine plus artemether, combination therapy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Children < 5 years of age (in one site, patients of all ages are eligible). Documented fever (axillary temperature >= 37.5oC) in the absence of another obvious cause of fever or other serious or chronic medical condition Unmixed infection with P. falciparum of between 2,000 and 250,000 asexual parasites/mm3 Patients' or the patients' parent's or guardian's informed consent and willingness to participate in the study Exclusion Criteria: Any evidence of severe malaria that would require hospitalization for treatment. Reported allergy to any antimalarial drugs, including sulfa and artemisinin drugs. History of pregnancy or delayed menstrual period Breastfeeding a child less than 8 weeks of age

Sites / Locations

Ngere Ngere Health Center
Ikwiriri Health Center
Lupiro Health Center

Outcomes

Primary Outcome Measures

Clinical and parasitologic failure rate

Secondary Outcome Measures

Full Information

NCT ID

NCT00140361

First Posted

August 30, 2005

Last Updated

September 10, 2012

Sponsor

Centers for Disease Control and Prevention

Collaborators

United States Agency for International Development (USAID)

1. Study Identification

Unique Protocol Identification Number

NCT00140361

Brief Title

Efficacy of Sulphadoxine-pyrimethamine and Artemisinin-containing Combination Therapy for Malaria

Official Title

Assessing and Monitoring the Efficacy of Sulfadoxine/ Pyrimethamine (SP) and the Combination of SP Plus Artesunate for Uncomplicated Malaria Infections Among Children

Study Type

Interventional

2. Study Status

Record Verification Date

September 2012

Overall Recruitment Status

Completed

Study Start Date

January 2000 (undefined)

Primary Completion Date

January 2008 (Actual)

Study Completion Date

January 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Centers for Disease Control and Prevention

Collaborators

United States Agency for International Development (USAID)

4. Oversight

Data Monitoring Committee

No

5. Study Description

Brief Summary

This is an ongoing monitoring activity of efficacy of sulfadoxine-pyrimethamine (SP), which is the current national treatment of choice for uncomplicated malaria in Tanzania, and a combination of SP and artesunate among children < 5 years in 3 sites in rural Tanzania. Protocol was amended in 2004 to (1) include lumefantrine+artemether, the newly identified first-line treatment for malaria to be introduced into Tanzania in 2006; (2) on a limited basis, include adult patients; (3) extend follow-up to 28 days; (4) investigate whether treated bednets would reduce confounding by reinfection

Detailed Description

This is an ongoing monitoring activity of efficacy of sulfadoxine-pyrimethamine (SP), which is the current national treatment of choice for uncomplicated malaria in Tanzania, and a combination of SP and artesunate among children < 5 years in 3 sites in rural Tanzania. Protocol was amended in 2004 to (1) include lumefantrine+artemether, the newly identified first-line treatment for malaria to be introduced into Tanzania in 2006; (2) on a limited basis, include adult patients; (3) extend follow-up to 28 days; (4) investigate whether treated bednets would reduce confounding by reinfection

6. Conditions and Keywords

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

Malaria (Uncomplicated)

Keywords

malaria, sulfadoxine-pyrimethamine, sulfadoxine-pyrimethamine plus artsunate, lumefantrine plus artemether, combination therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

390 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Sulfadoxine-pyrimethamine

Intervention Type

Drug

Intervention Name(s)

sulfadoxine-pyrimethamine plus artesunate

Intervention Type

Drug

Intervention Name(s)

lumefantrine plus artemether

Intervention Type

Behavioral

Intervention Name(s)

Sleeping under insecticide-treated bednet

Primary Outcome Measure Information:

Title

Clinical and parasitologic failure rate

10. Eligibility

Sex

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: Children < 5 years of age (in one site, patients of all ages are eligible). Documented fever (axillary temperature >= 37.5oC) in the absence of another obvious cause of fever or other serious or chronic medical condition Unmixed infection with P. falciparum of between 2,000 and 250,000 asexual parasites/mm3 Patients' or the patients' parent's or guardian's informed consent and willingness to participate in the study Exclusion Criteria: Any evidence of severe malaria that would require hospitalization for treatment. Reported allergy to any antimalarial drugs, including sulfa and artemisinin drugs. History of pregnancy or delayed menstrual period Breastfeeding a child less than 8 weeks of age

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Peter B Bloland, DVM, MPVM

Organizational Affiliation

Centers for Disease Control and Prevention

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Salim Abdulla, MD, PhD

Organizational Affiliation

Ifakara Health Research and Development Centre

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

John R MacArthur, MD, MPH

Organizational Affiliation

Centers for Disease Control and Prevention

Official's Role

Study Director

Facility Information:

Facility Name

Ngere Ngere Health Center

City

Ngere Ngere

State/Province

Morogoro Rural

Country

Tanzania

Facility Name

Ikwiriri Health Center

City

Ikwiriri

State/Province

Rufiji

Country

Tanzania

Facility Name

Lupiro Health Center

City

Lupiro

State/Province

Ulanga

Country

Tanzania

Malaria (Uncomplicated)

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial