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NCT Number: NCT00164710

Assessing the Efficacy of Four Drug Combinations as the Next First-line Therapy 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.

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Key information

Conditions

Malaria, Falciparum Infections Malaria Mosquito-Borne Diseases Parasitic Diseases Protozoan Infections Vector Borne Diseases

Age range

6 month–59 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Kawale Health Center, Lilongwe, Lilongwe District, Malawi

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sulfadoxine-Pyrimethamine

Drug

amodiaquine plus sulfadoxine-pyrimethamine

Drug

amodiaquine plus artesunate

Drug

chlorproguanil-dapsone plus artesunate

Drug

lumefantrine-artemether

Drug

Primary outcomes

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

Secondary outcomes

  1. • Rate of Adequate clinical and parasitological response 28 days

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

  3. • Incidence of adverse events during the period of observation

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

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

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

  7. • Percent of patients with a decrease in haemoglobin concentration

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

  9. • Prevalence of parasitemia on Day 2

  10. • Prevalence of parasitemia on Day 3

  11. • Gametocyte prevalence on Day 14

  12. • Gametocyte prevalence on Day 28

Sponsors and collaborators

Lead sponsor

Centers for Disease Control and Prevention

Fed

Collaborators

  • Ministry of Health, Malawi

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2005
Study completion
2005
First posted
Sep 14, 2005
Registry last updated
Sep 27, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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