Back to resultsEfficacy and Safety of Amodiaquine and Amodiaquine-Artesunate
Primary Purpose
Malaria
Status
Unknown status
Phase
Phase 4
Locations
Ghana
Study Type
Interventional
Intervention
amodiaquine-artesunate versus amodiaquine
Sponsored by
About this trial
This is an interventional treatment trial for Malaria focused on measuring malaria, amodiaquine, artesunate, safety, efficacy
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
Sites / Locations
- University for Development Studies
Outcomes
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
Full Information
NCT ID
NCT00238017
First Posted
October 7, 2005
Last Updated
February 1, 2006
Sponsor
Charite University, Berlin, Germany
Collaborators
University for Development Studies, Tamale, Ghana, Kintampo Health Research Centre, Ghana
1. Study Identification
Unique Protocol Identification Number
NCT00238017
Brief Title
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
2. Study Status
Record Verification Date
July 2005
Overall Recruitment Status
Unknown status
Study Start Date
October 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Charite University, Berlin, Germany
Collaborators
University for Development Studies, Tamale, Ghana, Kintampo Health Research Centre, Ghana
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malaria
Keywords
malaria, amodiaquine, artesunate, safety, efficacy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
400 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
amodiaquine-artesunate versus amodiaquine
Primary Outcome Measure Information:
Title
Parasitological and clinical cure rates by days 14 and 28
Title
Parasite and fever clearance times
Title
Carrier rates of sexual parasite stages at days 7, 14 and 28
Title
Incidence rates of adverse events
Secondary Outcome Measure Information:
Title
Incidence rate of haematological and biochemical evidence of drug-induced toxicity
Title
Primary endpoints in children with and without various genetic host factors
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
59 Months
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rowland N Otchwemah, PhD
Organizational Affiliation
University for Development Studies
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Frank P Mockenhaupt, MD
Organizational Affiliation
Malaria Unit, Institute of Tropical Medicine, Charite University, Berlin, Germany
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Seth Owusu-Agyei, PhD
Organizational Affiliation
Kintampo Health Research Centre, Ghana
Official's Role
Principal Investigator
Facility Information:
Facility Name
University for Development Studies
City
Tamale
State/Province
Northern Region
Country
Ghana
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of Amodiaquine and Amodiaquine-Artesunate
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