Try the modernized beta website. Learn more about the modernization effort.
Working… Menu

Kintampo Trial of Combination Therapy for Malaria

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00119145
Recruitment Status : Completed
First Posted : July 13, 2005
Last Update Posted : January 12, 2017
Kintampo Health Research Centre, Ghana
Information provided by (Responsible Party):
Brian Greenwood, London School of Hygiene and Tropical Medicine

Brief Summary:

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 or disease Intervention/treatment Phase
Malaria Drug: artesunate-amodiaquine Drug: coartem Drug: artesunate-lapdap Phase 4

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 510 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : June 2005
Actual Study Completion Date : May 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria

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

Secondary Outcome Measures :
  1. Parasitological cure rate by day 14
  2. Parasitological cure rate by day 28
  3. Clinical cure rates by days 14 and 28
  4. Incidence rates of adverse events
  5. Gametocyte carriage at days 7, 14 and 28

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   6 Months to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00119145

Layout table for location information
Kintampo Health Research Centre
Kintampo, Brong Ahafo Region, Ghana
Sponsors and Collaborators
London School of Hygiene and Tropical Medicine
Kintampo Health Research Centre, Ghana
Layout table for investigator information
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
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Brian Greenwood, Professor, London School of Hygiene and Tropical Medicine Identifier: NCT00119145    
Other Study ID Numbers: ITDCVG44
First Posted: July 13, 2005    Key Record Dates
Last Update Posted: January 12, 2017
Last Verified: January 2017
Keywords provided by Brian Greenwood, London School of Hygiene and Tropical Medicine:
antimalarial drugs
Additional relevant MeSH terms:
Layout table for MeSH terms
Protozoan Infections
Parasitic Diseases
Vector Borne Diseases
Artemether, Lumefantrine Drug Combination
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antineoplastic Agents
Antiviral Agents
Antiplatyhelmintic Agents