Efficacy and Safety of Amodiaquine and Amodiaquine-Artesunate - Full Text View

Sponsors and Collaborators:	Charite University, Berlin, Germany University for Development Studies, Tamale, Ghana Kintampo Health Research Centre, Ghana
Information provided by:	Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:	NCT00238017

Purpose

The purpose of this study is to compare the efficacy and safety of two antimalarial drug regimes, namely amodiaquine versus amodiaquine-artesunate, in the treatment of children with uncomplicated malaria. Also, genetic host factors which might influence efficacy and/or safety will be examined.

Condition	Intervention	Phase
Malaria	Drug: amodiaquine-artesunate versus amodiaquine	Phase IV

MedlinePlus related topics: Malaria

Drug Information available for: Artesunate Amodiaquine Amodiaquine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Double Blind Trial on the Efficacy and Safety of Amodiaquine-Artesunate and Amodiaquine Alone in the Treatment of Children With Uncomplicated Falciparum Malaria

Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:

Parasitological and clinical cure rates by days 14 and 28
Parasite and fever clearance times
Carrier rates of sexual parasite stages at days 7, 14 and 28
Incidence rates of adverse events

Secondary Outcome Measures:

Incidence rate of haematological and biochemical evidence of drug-induced toxicity
Primary endpoints in children with and without various genetic host factors

Estimated Enrollment:	400
Study Start Date:	October 2005
Estimated Study Completion Date:	December 2005

Detailed Description:

Malaria remains a major cause of morbidity and mortality among children in sub-Saharan Africa. Current malaria control largely consists of rapid treatment of patients. Amodiaquine-artesunate and other combinatory treatment regimes including amodiaquine are now being introduced as first-line antimalarial drugs in several African countries. However, data on the efficacy and safety of amodiaquine and amodiaquine-artesunate are scarce. In addition, there is evidence that common genetic host factors, e.g. sickle cell trait, may influence efficacy and safety of these drugs. To examine efficacy and safety of the named drugs as well as a potential influence of genetic host factors on these outcomes a randomized, double blind trial among 400 children with uncomplicated malaria is performed in northern Ghana.

Eligibility

Ages Eligible for Study:	6 Months to 59 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male and female outpatients aged 6 to 59 months
Body weight >5 kg
Uncomplicated Plasmodium falciparum malaria
Mono-infection with P. falciparum with an asexual parasite density between 2,000 to 200,000 parasites/μl
Axillary temperature ≥37.5°C
Ability to tolerate oral therapy
Informed consent by the legal representative of the subject
Residence in study area

Exclusion Criteria:

Previous participation in this clinical trial
Haemoglobin <5 mg/dl
Mixed plasmodial infection
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
History of allergy or intolerance against study medications

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00238017

Locations

Ghana, Northern Region
University for Development Studies
Tamale, Northern Region, Ghana

Sponsors and Collaborators

Charite University, Berlin, Germany

University for Development Studies, Tamale, Ghana

Kintampo Health Research Centre, Ghana

Investigators

Principal Investigator:	Rowland N Otchwemah, PhD	University for Development Studies
Principal Investigator:	Frank P Mockenhaupt, MD	Malaria Unit, Institute of Tropical Medicine, Charite University, Berlin, Germany
Principal Investigator:	Seth Owusu-Agyei, PhD	Kintampo Health Research Centre, Ghana

More Information

homepage: Northern Region Malaria Project This link exits the ClinicalTrials.gov site

Study ID Numbers:	NP05-M4, A50068
Study First Received:	October 7, 2005
Last Updated:	February 1, 2006
ClinicalTrials.gov Identifier:	NCT00238017
Health Authority:	Ghana: Ministry of Health

Keywords provided by Charite University, Berlin, Germany:

malaria, amodiaquine, artesunate, safety, efficacy

Study placed in the following topic categories:

Artesunate
Protozoan Infections
Amodiaquine

Parasitic Diseases
Malaria
Malaria, Falciparum

Additional relevant MeSH terms:

Anti-Infective Agents
Antimalarials
Antiparasitic Agents
Antiprotozoal Agents

Coccidiosis
Therapeutic Uses
Amebicides
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009