Clinical trial NCT00238017: Efficacy and Safety of Amodiaquine and Amodiaquine-Artesunate
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Malaria
Keywords: malaria, amodiaquine, artesunate, safety, efficacy
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: University for Development Studies, Tamale, Ghana
name: Kintampo Health Research Centre, Ghana
First posted: 2005-10-13
Enrollment: 400
Sex: ALL
Minimum age (years): 6
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 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

Primary outcomes:
measure: Parasitological and clinical cure rates by days 14 and 28
measure: Parasite and fever clearance times
measure: Carrier rates of sexual parasite stages at days 7, 14 and 28
measure: Incidence rates of adverse events
Secondary outcomes:
measure: Incidence rate of haematological and biochemical evidence of drug-induced toxicity
measure: Primary endpoints in children with and without various genetic host factors
Other outcomes:
Locations:
city: Tamale
country: Ghana
facility: University for Development Studies
state: Northern Region
Study officials:
affiliation: University for Development Studies
name: Rowland N Otchwemah, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Malaria Unit, Institute of Tropical Medicine, Charite University, Berlin, Germany
name: Frank P Mockenhaupt, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kintampo Health Research Centre, Ghana
name: Seth Owusu-Agyei, PhD
role: PRINCIPAL_INVESTIGATOR
References: