Efficacy and Safety of Amodiaquine and Amodiaquine-Artesunate

Malaria Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00238017
• Other study ID #: NP05-M4
• Secondary ID: A50068
• Status: Active, not recruiting
• Phase: Phase 4
• First received: October 7, 2005
• Last updated: February 1, 2006
• Start date: October 2005
• Est. completion date: December 2005

Study information

• Verified date: July 2005
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ghana: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 400
• Est. completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 59 Months

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malaria

Intervention

Drug:
• amodiaquine-artesunate versus amodiaquine

Locations

Country	Name	City	State
Ghana	University for Development Studies	Tamale	Northern Region

Sponsors (3)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	Kintampo Health Research Centre, Ghana, University for Development Studies, Tamale, Ghana

Country where clinical trial is conducted

Ghana, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Parasitological and clinical cure rates by days 14 and 28
Primary	Parasite and fever clearance times
Primary	Carrier rates of sexual parasite stages at days 7, 14 and 28
Primary	Incidence rates of adverse events
Secondary	Incidence rate of haematological and biochemical evidence of drug-induced toxicity
Secondary	Primary endpoints in children with and without various genetic host factors