Kintampo Trial of Combination Therapy for Malaria
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| ClinicalTrials.gov Identifier: NCT00119145 |
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Recruitment Status :
Completed
First Posted : July 13, 2005
Last Update Posted : January 12, 2017
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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 |
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| 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 |
- adequate clinical and Parasitological response (ACPR)by day 28.
- 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
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| 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
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 ClinicalTrials.gov identifier (NCT number): NCT00119145
| Ghana | |
| Kintampo Health Research Centre | |
| Kintampo, Brong Ahafo Region, Ghana | |
| 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 ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Brian Greenwood, Professor, London School of Hygiene and Tropical Medicine |
| ClinicalTrials.gov Identifier: | NCT00119145 History of Changes |
| 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:
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antimalarial drugs efficacy safety trial |
Additional relevant MeSH terms:
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Malaria Protozoan Infections Parasitic Diseases Artesunate Amodiaquine Artemether, Lumefantrine Drug Combination Antimalarials Antiprotozoal Agents |
Antiparasitic Agents Anti-Infective Agents Antineoplastic Agents Antiviral Agents Schistosomicides Antiplatyhelmintic Agents Anthelmintics |