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

September 26, 2012 updated by: Centers for Disease Control and Prevention

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

365

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Malawi
    • Lilongwe District
      • Lilongwe, Lilongwe District, Malawi
        • Kawale Health Center
    • Machinga District
      • Liwonde, Machinga District, Malawi
        • Machinga District Hospital
    • Nkhotakota District
      • Dwangwa, Nkhotakota District, Malawi
        • Matiki Health Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 4 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
• 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centers for Disease Control and Prevention

Collaborators

Ministry of Health and Population, Malawi

Investigators

  • Principal Investigator: Rachel N Bronzan, MD, MPH, Centers for Disease Control and Prevention

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2005

Primary Completion (Actual)

September 1, 2005

Study Completion (Actual)

September 1, 2005

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 14, 2005

Study Record Updates

Last Update Posted (Estimate)

September 27, 2012

Last Update Submitted That Met QC Criteria

September 26, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDC-NCID-4539
  • PA# 04018

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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