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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00164710
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : September 27, 2012
Sponsor:
Collaborator:
Ministry of Health and Population, Malawi
Information provided by (Responsible Party):
Centers for Disease Control and Prevention

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.

Condition or disease Intervention/treatment Phase
Malaria, Falciparum Drug: sulfadoxine-pyrimethamine Drug: amodiaquine plus sulfadoxine-pyrimethamine Drug: amodiaquine plus artesunate Drug: chlorproguanil-dapsone plus artesunate Drug: lumefantrine-artemether Phase 4

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Study Type : Interventional  (Clinical Trial)
Enrollment : 365 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : April 2005
Actual Primary Completion Date : September 2005
Actual Study Completion Date : September 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria




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

Secondary Outcome Measures :
  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


Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 59 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00164710


Locations
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Malawi
Kawale Health Center
Lilongwe, Lilongwe District, Malawi
Machinga District Hospital
Liwonde, Machinga District, Malawi
Matiki Health Center
Dwangwa, Nkhotakota District, Malawi
Sponsors and Collaborators
Centers for Disease Control and Prevention
Ministry of Health and Population, Malawi
Investigators
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Principal Investigator: Rachel N Bronzan, MD, MPH Centers for Disease Control and Prevention
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Responsible Party: Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT00164710    
Other Study ID Numbers: CDC-NCID-4539
PA# 04018
First Posted: September 14, 2005    Key Record Dates
Last Update Posted: September 27, 2012
Last Verified: September 2012
Keywords provided by Centers for Disease Control and Prevention:
antimalarials
Additional relevant MeSH terms:
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Malaria
Malaria, Falciparum
Protozoan Infections
Parasitic Diseases
Artesunate
Pyrimethamine
Lumefantrine
Artemether
Sulfadoxine
Fanasil, pyrimethamine drug combination
Amodiaquine
Dapsone
Chlorproguanil
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antineoplastic Agents
Antiviral Agents
Schistosomicides
Antiplatyhelmintic Agents
Anthelmintics
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents
Leprostatic Agents
Anti-Bacterial Agents