Kintampo Trial of Combination Therapy for Malaria

This study has been completed.
Sponsor:
Collaborator:
Kintampo Health Research Centre, Ghana
Information provided by:
Gates Malaria Partnership
ClinicalTrials.gov Identifier:
NCT00119145
First received: July 4, 2005
Last updated: February 7, 2008
Last verified: February 2008
  Purpose

Case management is one of the key strategies for malaria control in most endemic countries. Plasmodium falciparum malaria is becoming resistant to commonly used and cheap antimalarial drugs such as chloroquine, amodiaquine, and sulfadoxine-pyrimethamine (SP). Thus the safety and efficacy of new anti-malarial drugs need to be tested in sites with well-characterised malariometric indices in order to make appropriate treatment policies.

Artemisinin-based combination chemotherapies have been documented to consistently produce faster relief of clinical symptoms and parasite clearance in uncomplicated falciparum malaria than any other currently used antimalarial drugs. So far, artesunate-amodiaquine (AS-AQ) and artemether-lumefantrine (AR-LM) are the only two registered fixed-dose artemisinin combination chemotherapies produced at industrial scale, with good manufacturing practices and already used in Africa. Several African countries, including Ghana, are therefore introducing either AS-AQ or AR-LM as first-line antimalarials or evaluating the case for such a change. Clearly, a direct comparison of both the safety and efficacy profiles of the two combinations under different epidemiological conditions is urgently needed to guide informed decisions on the most appropriate antimalarial first-line treatment regimen.

This study aims to evaluate the efficacy and safety of artesunate-amodiaquine combination therapy, artemether-lumefantrine, and artesunate-lapdap in an open-labelled, randomised, non-inferiority drug trial.

The study results will inform future decisions on first- and second-line treatments for uncomplicated P. falciparum malaria with respect to efficacy and safety in Ghana.


Condition Intervention Phase
Malaria
Drug: artesunate-amodiaquine
Drug: coartem
Drug: artesunate-lapdap
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Non-Inferiority, Open-Labelled, Randomised Trial Of The Efficacy And Safety Of Artesunate-Amodiaquine, Artemether-Lumefantrine, And Artesunate-Lapdap For Treatment Of Uncomplicated P. Falciparum Malaria Among Children In Ghana

Resource links provided by NLM:


Further study details as provided by Gates Malaria Partnership:

Primary Outcome Measures:
  • adequate clinical and Parasitological response (ACPR)by day 28.

Secondary Outcome Measures:
  • Parasitological cure rate by day 14
  • Parasitological cure rate by day 28
  • Clinical cure rates by days 14 and 28
  • Incidence rates of adverse events
  • Gametocyte carriage at days 7, 14 and 28

Estimated Enrollment: 510
Study Start Date: June 2005
Study Completion Date: May 2006
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   6 Months to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 6 months to 10 years
  • Body weight >5 kg
  • Uncomplicated P. falciparum malaria
  • Mono-infection with P. falciparum
  • Asexual parasite density 2,000 to 200,000 parasites/µl
  • Haemoglobin ≥7.0 g/dL
  • Axillary temperature ≥37.5ºC or history of fever in preceding 24 hr
  • Ability to tolerate oral therapy
  • Residence in study area

Exclusion Criteria:

  • Haemoglobin <7.0 g/dL
  • Leucocyte count: >15,000/µL
  • G6PD deficiency
  • Mixed malaria infections
  • Danger signs (unable to drink; repeated vomiting; recent history of convulsions; lethargic or unconscious state; unable to stand up or to sit) and signs of severe malaria as defined by WHO
  • Any other severe underlying disease (cardiac, renal, hepatic diseases, malnutrition, known HIV infection)
  • Concomitant disease masking assessment of response, e.g. known or suspected hearing impairments
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00119145

Locations
Ghana
Kintampo Health Research Centre
Kintampo, Brong Ahafo Region, Ghana
Sponsors and Collaborators
Gates Malaria Partnership
Kintampo Health Research Centre, Ghana
Investigators
Principal Investigator: Seth Owusu-Agyei, PhD London School of Hygiene and Tropical Medicine
Principal Investigator: Daniel Chandramohan, MBBS, PhD London School of Hygiene and Tropical Medicine
Principal Investigator: Brian M Greenwood, FRCP, FRS London School of Hygiene and Tropical Medicine
  More Information

No publications provided by Gates Malaria Partnership

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00119145     History of Changes
Other Study ID Numbers: ITDCVG44
Study First Received: July 4, 2005
Last Updated: February 7, 2008
Health Authority: Ghana: Ministry of Health

Keywords provided by Gates Malaria Partnership:
antimalarial drugs
efficacy
safety
trial

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases
Amodiaquine
Artesunate
Artemether-lumefantrine combination
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Amebicides

ClinicalTrials.gov processed this record on August 28, 2014