Efficacy and Safety of Amodiaquine and Amodiaquine-Artesunate
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
2 other identifiers
interventional
400
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Oct 2005
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2005
CompletedFirst Submitted
Initial submission to the registry
October 7, 2005
CompletedFirst Posted
Study publicly available on registry
October 13, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2005
CompletedFebruary 2, 2006
July 1, 2005
October 7, 2005
February 1, 2006
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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 Outcomes (2)
Incidence rate of haematological and biochemical evidence of drug-induced toxicity
Primary endpoints in children with and without various genetic host factors
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University for Development Studies
Tamale, Northern Region, Ghana
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
October 7, 2005
First Posted
October 13, 2005
Study Start
October 1, 2005
Study Completion
December 1, 2005
Last Updated
February 2, 2006
Record last verified: 2005-07