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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

Tracking Information
First Submitted Date  ICMJE September 9, 2005
First Posted Date  ICMJE September 14, 2005
Last Update Posted Date September 27, 2012
Study Start Date  ICMJE April 2005
Actual Primary Completion Date September 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 9, 2005)
Incidence of abdominal pain on days 1, 2, and 3 in the two treatment groups
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 9, 2005)
  • 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 Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Amodiaquine Plus Artesunate Versus Lapdap Plus Artesunate in the Treatment of Uncomplicated P. Falciparum Malaria in Malawi
Official Title  ICMJE 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
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 Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Malaria, Falciparum
Intervention  ICMJE
  • Drug: Amodiaquine plus artesunate
  • Drug: chlorproguanil-dapsone plus artesunate
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: September 9, 2005)
212
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2005
Actual Primary Completion Date September 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 5 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Malawi
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00164359
Other Study ID Numbers  ICMJE CDC-NCID-4538
PA#04018
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Centers for Disease Control and Prevention
Study Sponsor  ICMJE Centers for Disease Control and Prevention
Collaborators  ICMJE Ministry of Health and Population, Malawi
Investigators  ICMJE
Principal Investigator: Rachel N Bronzan, MD, MPH Centers for Disease Control and Prevention
PRS Account Centers for Disease Control and Prevention
Verification Date September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP