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Amodiaquine Plus Artesunate Versus Lapdap Plus Artesunate in the Treatment of Uncomplicated P. Falciparum Malaria in Malawi

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ClinicalTrials.gov Identifier: NCT00164359
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 is the current first-line therapy for uncomplicated malaria in Malawi. Significant resistance of the P. falciparum malaria parasite to this drug has led to an imminent need for the government of Malawi to identify a new first-line therapy for uncomplicated malaria and to implement that new therapy as policy. This protocol is the second of two protocols whose combined purpose is to provide efficacy and side effect data on four antimalarial drug combinations that are candidates for the next first-line therapy for uncomplicated malaria in Malawi. This protocol aims to assess the acceptability and tolerability of amodiaquine in Malawi. It is a double-blind study comparing amodiaquine plus artesunate (AQ-Art, one of the candidate combination therapies) to chlorproguanil/dapsone plus artesunate (CD-Art, another of the candidate combination therapies) in persons 5 years and older, to see if there is a higher incidence of abdominal pain and/or refusal to take the therapy in the AQ-Art group. Amodiaquine was removed from the Malawian national drug registry in 1995 because of a perceived association with abdominal pain. Although no studies were conducted to substantiate this, consensus among clinicians was that patients were refusing amodiaquine with increasing frequency, citing abdominal pain as the reason, so the drug was removed from the registry. Results from this study, along with the efficacy data from the sister protocol in children under five years of age, will help guide the National Malaria Control Program of Malawi in selecting their next first-line antimalarial therapy.

Condition or disease Intervention/treatment Phase
Malaria, Falciparum Drug: Amodiaquine plus artesunate Drug: chlorproguanil-dapsone plus artesunate Phase 4

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Study Type : Interventional  (Clinical Trial)
Enrollment : 212 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Double-blind Randomised Trial to Assess the Tolerability of Amodiaquine Plus Artesunate (AQ-Art) Versus Chlorproguanil Plus Dapsone Plus Artesunate (CDA) in the Treatment of Uncomplicated P. Falciparum 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
Drug Information available for: Dapsone




Primary Outcome Measures :
  1. Incidence of abdominal pain on days 1, 2, and 3 in the two treatment groups

Secondary Outcome Measures :
  1. Rate of adequate clinical and parasitological response at 14 days
  2. Rate of adequate clinical and parasitological response at 28 days
  3. Mean percent change in blood haemoglobin concentration between day 0 and day 28
  4. Incidence of adverse events other than abdominal pain during the period of observation
  5. Rate of Early Treatment Failure (per WHO definition)
  6. Rate of Late Clinical Failure (per WHO definition)
  7. Rate of Late Parasitological Failure (per WHO definition)
  8. Percent of patients with a decrease in haemoglobin concentration
  9. Percent of patients with a decrease in haemoglobin concentration of >= 2g/dl
  10. Prevalence of parasitemia on Day 2
  11. Prevalence of parasitemia on Day 3
  12. Gametocyte prevalence on Day 14
  13. Gametocyte prevalence on day 28


Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age five years or older
  • Axillary temperature >= 37.5 degrees Celsius
  • Monoinfection with P. falciparum
  • Parasitemia between 2000 and 200000 parasites/microliter
  • Hemoglobin concentration >= 7g/dl
  • Consent by the patient of patient's adult guardian
  • Residence in the locality and willingness to attend for scheduled visits
  • Negative urine pregnancy test in women age twelve years and older

Exclusion Criteria:

  • Signs of severe or complicated malaria
  • altered consciousness
  • convulsions
  • prostration (inability to sit/stand/suck/drink)
  • respiratory distress or breathlessness
  • jaundice
  • abnormal breathing
  • hemoglobinuria
  • 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 edema 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): NCT00164359


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: NCT00164359     History of Changes
Other Study ID Numbers: CDC-NCID-4538
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:
malaria, falciparum
antimalarials
Additional relevant MeSH terms:
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Malaria
Malaria, Falciparum
Protozoan Infections
Parasitic Diseases
Artesunate
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
Leprostatic Agents
Anti-Bacterial Agents