Skip to main content
OpenTrials
Completed

NCT Number: NCT00164359

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

5 year and older

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

  • 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

Treatment and study plan

amodiaquine plus artesunate

Drug

chlorproguanil-dapsone plus artesunate

Drug

Primary outcomes

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

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Centers for Disease Control and Prevention

Fed

Collaborators

  • Ministry of Health, Malawi

Registry information

Official study 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

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.