MalariaPhase 4NCT00238017
Efficacy and Safety of Amodiaquine and Amodiaquine-Artesunate
A Phase 4 study testing amodiaquine-artesunate versus amodiaquine in people with Malaria, run by Charite University, Berlin, Germany at 1 site in Ghana.
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. Read more about this study
- Who is it for?
- Ages 6 to 59 months
- Conditions the study is for
- Malaria
- What is being tested?
- amodiaquine-artesunate versus amodiaquine
- How many people
- 400 participants
- Where
- 1 siteGhana
- Study dates
- Oct 2005to Dec 2005
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 59 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this 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
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.
Read the 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.
- Conditions
- Malaria
- Being tested
- amodiaquine-artesunate versus amodiaquine
- Keywords
- malaria, amodiaquine, artesunate, safety, efficacy
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
amodiaquine-artesunate versus amodiaquineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2005 (estimated)
- Study startOct 2005
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalariaStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 400 participants
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- University for Development Studies, Tamale, Ghana, Kintampo Health Research Centre, Ghana
- Investigators
- Rowland N Otchwemah, PhD, Principal investigator, University for Development StudiesFrank P Mockenhaupt, MD, Principal investigator, Malaria Unit, Institute of Tropical Medicine, Charite University, Berlin, GermanySeth Owusu-Agyei, PhD, Principal investigator, Kintampo Health Research Centre, Ghana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00238017
- Sponsor's protocol ID
- NP05-M4
- Other IDs
- A50068
- Status last verified
- Jul 2005
- First submitted
- 7 Oct 2005
- Last updated
- 2 Feb 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00238017
- Acronym / sponsor ID
- NP05-M4
- Conditions
- Malaria
- Keywords
- malaria, amodiaquine, artesunate, safety, efficacy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- University for Development Studies, Tamale, Ghana, Kintampo Health Research Centre, Ghana
- Study start
- Oct 2005
- Study completion
- Dec 2005
- First posted
- 13 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 6 to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| amodiaquine-artesunate versus amodiaquine | Drug | – |
Primary outcome
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
2 secondary outcomes
Incidence rate of haematological and biochemical evidence of drug-induced toxicity
Primary endpoints in children with and without various genetic host factors
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rowland N Otchwemah, PhD principal investigator
University for Development Studies
Frank P Mockenhaupt, MD principal investigator
Malaria Unit, Institute of Tropical Medicine, Charite University, Berlin, Germany
Seth Owusu-Agyei, PhD principal investigator
Kintampo Health Research Centre, Ghana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing amodiaquine-artesunate versus amodiaquine in people with Malaria, run by Charite University, Berlin, Germany at 1 site in Ghana.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Feb 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ghana. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parasitological and clinical cure rates by days 14 and 28. The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2006.