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Assessing the Efficacy of Four Drug Combinations as the Next First-line Therapy for Uncomplicated Malaria in Malawi

Primary Purpose

Malaria, Falciparum

Status

Completed

Phase

Phase 4

Locations

Malawi

Study Type

Interventional

Intervention

sulfadoxine-pyrimethamine

amodiaquine plus sulfadoxine-pyrimethamine

amodiaquine plus artesunate

chlorproguanil-dapsone plus artesunate

lumefantrine-artemether

About this trial

This is an interventional treatment trial for Malaria, Falciparum focused on measuring antimalarials

Eligibility Criteria

6 Months - 59 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Children age 6 - 59 months Axillary temperature ≥ 37.5 °C Monoinfection with P. falciparum Parasitaemia between 2000 - 200000 parasites/µl Haemoglobin concentration (finger-prick blood sample by HemoCue) > 7g/dl Consent by the patient's adult guardian Residence in the locality and willingness to attend for scheduled visits Exclusion Criteria: altered consciousness convulsions prostration (inability to sit/stand/suck/drink) respiratory distress or breathlessness jaundice abnormal breathing haemoglobinuria circulatory collapse persistent vomiting (cannot keep down liquids) evidence of a diagnosis other than malaria on physical examination presence of mixed infection presence of severe malnutrition (as evidenced by symmetrical oedema involving at least the feet, light hair color, or cachexia) contraindications to the antimalarial drugs used, especially history of allergy history of receiving a drug with antimalarial activity in the week prior to enrollment

Sites / Locations

Kawale Health Center
Machinga District Hospital
Matiki Health Center

Outcomes

Primary Outcome Measures

• Rate of Adequate Clinical and Parasitological Response at 14 days (WHO-defined measure of efficacy)

Secondary Outcome Measures

• Rate of Adequate clinical and parasitological response 28 days

• Mean percent change in blood haemoglobin concentration between day 0 and day 28

• Incidence of adverse events during the period of observation

• Rate of Early Treatment Failure (as defined by the WHO in their 2003 standardized protocol for assessing antimalarial drug efficacy)

• Rate of Late Clinical Failure (as defined by the WHO)

• Rate of Late Parasitologic Failure (as defined by the WHO)

• Percent of patients with a decrease in haemoglobin concentration

• Percent of patients with a decrease in haemoglobin concentration of ≥ 2g/dl

• Prevalence of parasitemia on Day 2

• Prevalence of parasitemia on Day 3

• Gametocyte prevalence on Day 14

• Gametocyte prevalence on Day 28

Full Information

NCT ID

NCT00164710

First Posted

September 13, 2005

Last Updated

September 26, 2012

Sponsor

Centers for Disease Control and Prevention

Collaborators

Ministry of Health and Population, Malawi

1. Study Identification

Unique Protocol Identification Number

NCT00164710

Brief Title

Assessing the Efficacy of Four Drug Combinations as the Next First-line Therapy for Uncomplicated Malaria in Malawi

Official Title

An Open Randomised Trial of the Efficacy of Sulfadoxine-Pyrimethamine (SP), Amodiaquine + SP (AQ-SP), AQ + Artesunate (AQ-Art), Chlorproguanil-Dapsone + Art (CD-Art), and Lumefantrine-Artemether (LA) for Uncomplicated Malaria in Malawi

Study Type

Interventional

2. Study Status

Record Verification Date

September 2012

Overall Recruitment Status

Completed

Study Start Date

April 2005 (undefined)

Primary Completion Date

September 2005 (Actual)

Study Completion Date

September 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Centers for Disease Control and Prevention

Collaborators

Ministry of Health and Population, Malawi

4. Oversight

5. Study Description

Brief Summary

Sulfadoxine-pyrimethamine (SP) is the current first-line treatment for uncomplicated malaria in Malawi. The malaria parasite P. falciparum has developed resistance to this drug so that the drug is much less effective than in previous years. This study was developed and conducted in collaboration with the National Malaria Control Programme of Malawi to assess the efficacy of four antimalarial drug combinations to provide evidence to assist the Malawian Ministry of Health in identifying and implementing as policy the next first-line antimalarial for uncomplicated malaria in Malawi. In an open, randomized trial in children under five years of age, four drug combinations, all of which are licensed in Malawi, are being assessed: amodiaquine plus sulfadoxine-pyrimethamine (AQ-SP), amodiaquine plus artesunate (AQ-Art), chlorproguanil-dapsone plus artesunate (CD-Art) and lumefantrine-artemether (LA). SP is also included as a fifth arm of the study for current data on its efficacy. Data on side effects of the drugs will also be collected. The results of this study will provide some of the information necessary to guide the Malawi National Malaria Control Program in selecting its next first antimalarial treatment for uncomplicated malaria. The study adheres to the World Health Organization's 2003 standardized protocol for assessing antimalarial drug efficacy.

6. Conditions and Keywords

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

Malaria, Falciparum

Keywords

antimalarials

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

365 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

sulfadoxine-pyrimethamine

Intervention Type

Drug

Intervention Name(s)

amodiaquine plus sulfadoxine-pyrimethamine

Intervention Type

Drug

Intervention Name(s)

amodiaquine plus artesunate

Intervention Type

Drug

Intervention Name(s)

chlorproguanil-dapsone plus artesunate

Intervention Type

Drug

Intervention Name(s)

lumefantrine-artemether

Primary Outcome Measure Information:

Title

• Rate of Adequate Clinical and Parasitological Response at 14 days (WHO-defined measure of efficacy)

Secondary Outcome Measure Information:

Title

• Rate of Adequate clinical and parasitological response 28 days

Title

• Mean percent change in blood haemoglobin concentration between day 0 and day 28

Title

• Incidence of adverse events during the period of observation

Title

• Rate of Early Treatment Failure (as defined by the WHO in their 2003 standardized protocol for assessing antimalarial drug efficacy)

Title

• Rate of Late Clinical Failure (as defined by the WHO)

Title

• Rate of Late Parasitologic Failure (as defined by the WHO)

Title

• Percent of patients with a decrease in haemoglobin concentration

Title

• Percent of patients with a decrease in haemoglobin concentration of ≥ 2g/dl

Title

• Prevalence of parasitemia on Day 2

Title

• Prevalence of parasitemia on Day 3

Title

• Gametocyte prevalence on Day 14

Title

• Gametocyte prevalence on Day 28

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Months

Maximum Age & Unit of Time

59 Months

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rachel N Bronzan, MD, MPH

Organizational Affiliation

Centers for Disease Control and Prevention

Official's Role

Principal Investigator

Facility Information:

Facility Name

Kawale Health Center

City

Lilongwe

State/Province

Lilongwe District

Country

Malawi

Facility Name

Machinga District Hospital

City

Liwonde

State/Province

Machinga District

Country

Malawi

Facility Name

Matiki Health Center

City

Dwangwa

State/Province

Nkhotakota District

Country

Malawi

12. IPD Sharing Statement

Learn more about this trial

Assessing the Efficacy of Four Drug Combinations as the Next First-line Therapy for Uncomplicated Malaria in Malawi

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