Malaria Clinical Trial
Official title:
Phase III Study to Study the Clinical Response to ACT Fixed Dose Combination in 42 Days in Uncomplicated Malaria in Cameroon
NCT number | NCT01845701 |
Other study ID # | A60041 |
Secondary ID | |
Status | Completed |
Phase | Phase 3 |
First received | |
Last updated | |
Start date | March 2010 |
Est. completion date | April 2015 |
Verified date | September 2018 |
Source | University of Yaounde 1 |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To assess the efficacy of artesunate-amodiaquine, dihydroartemisinin-piperaquine, in
comparison with artemether-lumefantrine during 42 days follow up period in 720 children with
acute uncomplicated P. falciparum malaria, in two different endemic ecological areas -
Savanna and equatorial forest regions of Cameroon.
We have set as specific objectives:
- To assess the efficacy of artesunate-amodiaquine, dihydroartemisinin-piperaquine, in
comparison with artemether-lumefantrine during 14 and 28 days follow up period in
children with acute uncomplicated P. falciparum malaria in two different endemic areas.
- To evaluate the safety of artesunate-amodiaquine, dihydroartemisinin-piperaquine, in
comparison with artemether-lumefantrine during 42 days follow up period in children with
acute uncomplicated P. falciparum malaria.
- To determine parasite clearance time (PCT) and fever clearance time (FCT) following the
administration of the three trial regimens.
- To investigate the treatment response based on WHO criteria (WHO, 2003) in patients in
all groups after trial.
- To investigate the Single Nucleotide Polymorphisms (SNPs) and microsatellite markers of
genes associated with drug resistance
Status | Completed |
Enrollment | 720 |
Est. completion date | April 2015 |
Est. primary completion date | April 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Months to 120 Months |
Eligibility |
Inclusion Criteria: - Children of either gender, aged between 6 months (> 5kg) and 10 years. - Suffering from acute uncomplicated P. falciparum malaria confirmed by microscopy using Giemsa-stained thick film with an asexual parasite density of 1,000 to 100,000 parasites/µl. - Presenting with fever (axillary temperature = 37.5oC) or having a history of fever in the preceding 24 hours. - Able to ingest tablets orally (either suspended in water or uncrushed with food). - Willing to participate in the study with written assent from parent/guardian. Parental authorization will be obtained for children less than 8 years old and documented assent of parents/guardians for children 8-10 years. - Willing and able to attend the clinic on stipulated regular follow-up visits. Exclusion Criteria: •Any of the following "danger signs of severe malaria": Not able to drink or breast feed Persistent vomiting (>2 episodes within previous 24 hours) Convulsions (>1 episode within previous 24 hours) Lethargic/unconscious - Signs/symptoms indicating severe/complicated malaria according to WHO criteria (WHO definition). - Concomitant illnesses, underlying chronic hepatic or renal disease, abnormal cardiac rhythm, hypoglycaemia, jaundice, respiratory distress, - Serious gastrointestinal disease, severe malnutrition (W/H < 70%) or severe anaemia (haemoglobin < 5 g/dl). - Known hypersensitivity to the study drugs. |
Country | Name | City | State |
---|---|---|---|
Cameroon | L'Hopital de District Ngong, Garoua, | Garoua | North |
Cameroon | Baptist Hospital | Mutengene | South West |
Lead Sponsor | Collaborator |
---|---|
University of Yaounde 1 | Gates Malaria Partnership, World Health Organization |
Cameroon,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinical Efficacy | Patient's trial outcome will be classified according to the WHO guidelines (WHO 2003) with application as follows: Early Treatment Failure (ETF); Late Clinical Failure (LCF); Late Parasitological Failure (LPF); Adequate Clinical and Parasitological Response (ACPR) - Absence of parasitaemia on day 42 irrespective of temperature without previously meeting any of the criteria of early treatment failure or late clinical failure or late parasitological failure | 42 days | |
Secondary | Safety by measure of changes in Physiologic, Blood, Liver and Kidney functions to define AE & SAEs | Prevalence of adverse events (AEs) and serious adverse events (SAEs): proportion of patients who experience AEs or SAEs during the follow up period of 42 days. Changes in vital Physiologic parameters (blood pressure, pulse rate): proportion of patients who have significant changes in vital signs comparing to baseline during the follow up period of 42 days. Prevalence of abnormal laboratory tests: proportion of patients who have abnormal values of laboratory tests (ALAT, ASAT, Bilirubin, Creatinine, Glucose, Urea etc), during the follow up period of 42 days. |
42 days |
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