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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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PACTR |
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Last refreshed on:
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29 April 2013 |
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Main ID: |
PACTR2009010000911750 |
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Date of registration:
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10/11/2008 |
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Primary sponsor: |
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Public title:
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4 ACT for uncomplicated malaria in African children
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Scientific title:
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Evaluation of 4 Artemisinin-Based Combinations for Treating Uncomplicated Malaria in African Children |
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Date of first enrolment:
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Target sample size:
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Recruitment status: |
Closed to recruitment: follow up continuing |
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URL:
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HTTP://www.pactr.org/ATMWeb/appmanager/atm/atmregistry?da=true&tno=PACTR2009010000911750 |
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Study type:
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interventional |
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Study design:
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Parallel: different groups receive different interventions at same time during study,
Randomised,
Block randomisation of variable size. ,
Sealed opaque envelopes,
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Countries of recruitment
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South Africa
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Contacts
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Name:
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Raffaella
Ravinetto |
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Address:
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Nationalestraat 155
2000
Antwerp
Belgium |
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Telephone:
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32 3 247 6625 |
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Email:
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rravinetto@itg.be |
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Affiliation:
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Head Clinical Trial Unit |
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Name:
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Maaike
De Crop |
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Address:
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Nationalestraat 155
2000
Antwerp
Belgium |
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Telephone:
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32 3 247 67 16 |
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Email:
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mdecrop@itg.be |
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Affiliation:
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Trial Manager |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Weight b 5 kg;
2. Monoinfection with P. falciparum and a parasitaemia of 2,000-200,000 asexual parasites per ?l;
3. Fever (axillary temperature ?37.5 ?C) or history of fever in the preceding 24 hours;
4. Haemoglobin value more or equal to 7.0 g/dl;
5. Signed informed consent by the parents or guardians;
6. Parents' or guardians' willingness and ability to comply with the study protocol for the duration of the trial
Exclusion criteria: 1. Participation in any other investigational drug study (antimalarial
or others) during the previous 30 days
2. Known hypersensitivity to the study drugs
3. Severe malaria
4. Danger signs: not able to drink or breast-feed, vomiting (b twice in
24hours), recent history of convulsions (b1 in 24h), unconscious state, unable to sit or stand;
5. Presence of intercurrent illness or any condition (cardiac, renal, hepatic diseases) which would place the subject at undue risk or interfere with the results of the study, including known G6PD deficiency
6. Severe malnutrition (defined as weight for height `70% of the median
NCHS/WHO reference)
7. Ongoing prophylaxis with drugs having antimalarial activity such as cotrimoxazole for the prevention of Pneumocisti carini pneumonia in children born to HIV+ women
Age minimum:
0 null
Age maximum:
4 null
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Malaria
null
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Primary Outcome(s)
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PCR adjusted treatment failure up to day 28 (TF28A): all early failures before day 14 plus the recurrent parasitaemias detected at day 14 or later and classified by genotyping as recrudescence
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PCR unadjusted treatment failure (TF28U): all treatment failures detected during the active follow up, regardless of genotyping
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Source(s) of Monetary Support
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EDCTP
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MMV
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