Kintampo Trial of Combination Therapy for Malaria

NCT00119145 | Completed Phase 4 DMC

• 1 other identifier: ITDCVG44
• Study Type: interventional
• Target: 510
• Locations: 1 country
• Sites: 1

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.

Conditions

Malaria

Keywords

antimalarial drugs; efficacy; safety; trial

Outcome Measures

Primary Outcomes (1)

• adequate clinical and Parasitological response (ACPR)by day 28.

Secondary Outcomes (5)

• 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

Interventions

artesunate-amodiaquine DRUG

coartem DRUG

artesunate-lapdap DRUG

Eligibility Criteria

• Age: 6 Months - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• London School of Hygiene and Tropical Medicine: lead
• Kintampo Health Research Centre, Ghana: collaborator

Study Sites (1)

Kintampo Health Research Centre

Kintampo, Brong Ahafo Region, Ghana

Location

Related Publications (1)

• Owusu-Agyei S, Asante KP, Owusu R, Adjuik M, Amenga-Etego S, Dosoo DK, Gyapong J, Greenwood B, Chandramohan D. An open label, randomised trial of artesunate+amodiaquine, artesunate+chlorproguanil-dapsone and artemether-lumefantrine for the treatment of uncomplicated malaria. PLoS One. 2008 Jun 25;3(6):e2530. doi: 10.1371/journal.pone.0002530.

  PMID: 18575626 DERIVED

MeSH Terms

Conditions

Malaria

Interventions

amodiaquine, artesunate drug combination; Artemether, Lumefantrine Drug Combination

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Artemether; Artemisinins; Reactive Oxygen Species; Free Radicals; Inorganic Chemicals; Organic Chemicals; Lumefantrine; Fluorenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sesquiterpenes; Terpenes; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 4, 2005
• First Posted: July 13, 2005
• Study Start: June 1, 2005
• Study Completion: May 1, 2006
• Last Updated: January 12, 2017

Record last verified: 2017-01

Locations

GH (1)