Safety and Efficacy Dose of Artesunate Used in Combination With LAPDAP Treatment of Uncomplicated Falciparum Malaria

This study has been completed.
Medicines for Malaria Venture
Information provided by:
GlaxoSmithKline Identifier:
First received: August 20, 2007
Last updated: August 21, 2007
Last verified: August 2007

Drug resistance to a range of antimalarial treatments has become widespread in Africa, South East Asia and South America. Because the rapid spread of drug resistance threatens a public health disaster in these areas of the world and to comply with the WHO-Roll Back Malaria policy of using Artemisinin-based combination therapies (ACT), there is a need to develop new, safe, effective and affordable ACT.

Chlorproguanil-dapsone-artesunate (CDA)is a new ACT that is being developed for the treatment of uncomplicated falciparum malaria in Africa.

Condition Intervention Phase
Drug: Chlorproguanil-dapsone-artesunate (CDA)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open, Randomised, Multi-Centre Dose Ranging Phase II Study to Evaluate LAPDAP in Combination With Three Different Doses of Artesunate

Resource links provided by NLM:

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Treatment differences between 1,2, or 4mg/kg artesunate with a fixed dose of Chlorproguanil-dapsone (LAPDAP), as measured by determination of PC90 (time to achieve reduction of parasitaemia by 90% of baseline)

Secondary Outcome Measures:
  • The key secondary efficacy endpoint is parasite viability (the proportion of ring-form parasites developing to schizonts) determined from rich adult data and confirmed with more sparse child data

Enrollment: 120
Study Start Date: June 2003

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Presentation to a healthcare facility with probable uncomplicated clinical malaria
  • Adults aged between 18 and 60 years , or children aged between 12 and 120 months
  • Weight between 5 and 85kg
  • Pure [on microscopic grounds] screening P. falciparum parasitaemia in children from 25,000 to 100,000ul-1, or in adults from 10,000 to 100,000ul-1. [The parasitaemia range for adults was originally set at 25,000 to 100,000µl-1 and changed to 10,000 to 100,000µl-1 in protocol amendment 3 dated 05 May 2004]
  • Written or oral witnessed consent obtained from subject, parent or guardian
  • Compliance with the requirements of the protocol which include a hospital stay of 4 days and 3 nights and regular blood samples by finger-prick (children) or via a cannula (adults)
  • A negative pregnancy test for women of child-bearing age on enrolment

Exclusion Criteria:

  • Features of severe/complicated falciparum malaria
  • Known allergy to sulphonamides
  • Evidence of any concomitant infection at the time of presentation (including P. ovale and P. malaria)
  • Any other underlying disease that would compromise the diagnosis and the evaluation of the response to the study medication (including clinical symptoms of immunosuppression, tuberculosis and bacterial infection)
  • Treatment in the 28-days prior to screening with sulfadoxine/pyrimethamine (FANSIDAR, CELOXINE), sulfalene/pyrimethamine (METAKELFIN), mefloquine-sulfadoxinepyrimethamine (FANSIMET), chloroquine* (NIVAQUINE); treatment in the 21-days prior to screening with mefloquine, or 7-days prior to screening with amodiaquine, halofantrine, quinine (full course), atovaquone - proguanil, artemisinins, co-artemether, tetracycline or clindamycin, or treatment for 5 half-lives prior to screening with drugs that have a potential anti-malarial activity (e.g. co-trimoxazole in the previous 60 hours)
  • Use of an investigational drug within 30 days or 5 half-lives (whichever is longer) prior to screening
  • Previous participation in this study
  • A positive pregnancy test at enrolment, women of child-bearing age who do not take a pregnancy test or female subjects who are breast-feeding an infant for the duration of the study
  Contacts and Locations
Please refer to this study by its identifier: NCT00519467

GSK Clinical Trials Call Center
Banjul, Gambia, PO Box 273
GSK Clinical Trials Call Center
Blantyre, Malawi, PO Box 95
Sponsors and Collaborators
Medicines for Malaria Venture
Study Director: GSK Clinical Trials, M.D GlaxoSmithKline
  More Information

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00519467     History of Changes
Other Study ID Numbers: SB-714703/003
Study First Received: August 20, 2007
Last Updated: August 21, 2007
Health Authority: Malawi: College of Medicine Research and Ethics Committee

Keywords provided by GlaxoSmithKline:
dose-ranging study

Additional relevant MeSH terms:
Protozoan Infections
Parasitic Diseases
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Leprostatic Agents
Anti-Bacterial Agents
Antimetabolites processed this record on April 17, 2014