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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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.

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.

Detailed Summary:
Sponsor: Centers for Disease Control and Prevention

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

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Rate of adequate clinical and parasitological response at 14 days
  • Rate of adequate clinical and parasitological response at 28 days
  • Mean percent change in blood haemoglobin concentration between day 0 and day 28
  • Incidence of adverse events other than abdominal pain during the period of observation
  • Rate of Early Treatment Failure (per WHO definition)
  • Rate of Late Clinical Failure (per WHO definition)
  • Rate of Late Parasitological Failure (per WHO definition)
  • 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


Original Secondary Outcome: Same as current

Information By: Centers for Disease Control and Prevention

Dates:
Date Received: September 9, 2005
Date Started: April 2005
Date Completion:
Last Updated: September 26, 2012
Last Verified: September 2012