Antimalaria Drugs Susceptibility Testing for an Effective Management of Infected Patients in Sub-Sahara Africa
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|ClinicalTrials.gov Identifier: NCT02974348|
Recruitment Status : Completed
First Posted : November 28, 2016
Last Update Posted : November 29, 2016
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The antimalarial drugs efficacy and safety study will be conducted in the Clinics and hospital of the Cameroon Development Corporation (CDC) Estates, Tiko Health District, located in a typical forest and rainfall area in the South West Region Cameroon. In this study, 350 children aged 6 months to 5 years who are found to have uncomplicated symptomatic malaria will be enrolled between October 2012 and March 2013. Participants will be randomized to receive one of the following medications.
(i) DHA+PQ : dihydroartemisinin, 2.5 mg per kg, plus piperaquine phosphate, 20mg per kg daily for 3 days; (ii) ART LUM : Artemether, 2mg per kg, plus lumefantrine 10mg, twice daily for 3 days; (iii) AS+MQ: artesunate, 4 mg/kg/day, with mefloquine, 8 mg/kg/day orally once a day for 3 days.
All study medications will be administered orally The Primary objective of this study are to compare the efficacy, safety and tolerability of orally administered artemether plus lumefantrine (ART+LUM), artesunate plus mefloquine (AS+MQ) and dihydroartemisinin plus piperaquine (DHA+PQ) combinations in the treatment of uncomplicated falciparum malaria in Cameroon in order to provide evidence that can be used to determining the optimum antimalaria treatment policy in Cameroon. The secondary objectives are as follows (i) To valuate the efficacy and safety of artemether plus lumefantrine (ART + LUM) and artesunate plus mefloquine (AS + MQ) versus dihydroartemisinin plus piperaquine (DHA + PQ) combination (ii) To compare the clearance of asexual parasites and gametocytes in each treatment arm (iii) To assess the clearance of fever (iv) Assess effect of each treatment arm on anemia This study is a randomized, double blinded clinical trial. After enrollment, participant will be randomized to one of the three treatment regimen. The treatment outcome will be assessed through a 42-day efficacy study. Participants who will exhibit early or late treatment failure and those with adequate clinical response and parasitological failure on day 14, 28 or 42 will be treated with quinine (25mg base per kg body weight per day in three divided doses for five days). In addition to antimalarial drugs oral paracetamol (50mg/kg body weight per day in three divided doses) will be administered for fever exceeding 37.5%. Polymerase Chain Reaction (PCR) -corrected 28 day and 42 day efficacy will be evaluated for each treatment episode.
|Condition or disease||Intervention/treatment||Phase|
|Drug Resistant Malaria Due to Plasmodium Falciparum||Drug: Arthemeter-lumefantrine Drug: Artesunate mefloquine Drug: Dihydroartemisinin piperaquine Drug: Paracetamol Drug: Amoxicillin Drug: Quinine||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Assessment of Antimalaria Drugs Susceptibility Testing for an Effective Management of Infected Patients in Sub-Sahara Africa|
|Study Start Date :||January 2013|
|Actual Primary Completion Date :||May 2013|
|Actual Study Completion Date :||October 2014|
Active Comparator: arm 1: Arthemeter-lumefantrine
Arthemeter-lumefantrine (ART-LUM) is an antimalaria drug manufactured as fixed combination tablets, each containing 20 mg of artemether and 120 mg of lumefantrine. ART-LUM was administrated according to body weight as six consecutive doses: The first dose at diagnosis and the second dose eight hours later, 0- 24-48 hours
Randomization codes were computer-generated by an offsite investigator and provided to a study nurse responsible for treatment allocation. All other study personnel were blinded to the treatment assignments, and patients were not informed of their treatment regimen. Participants from Group 1: AL, Group 2 : DHAP, Group3 : ASMQ were also given appointment card for days 1, 2, 3, 7, 14, 21, 28, 35 and 42 for clinical examination and blood smears. Blood was taken on filter paper on each of these visits.
Other Name: Cofantrine®
Active Comparator: arm 2 : Artesunate mefloquine
Artesunate mefloquine (ASMQ) is an antimalaria drug administered as a combination of artesunate, 4 mg/kg/day, with mefloquine, 8 mg/kg/day orally once a day for 3 days or three times, at an interval of 24 hours (0 h - 24 h - 48 h).
Drug: Artesunate mefloquine
Artequin® is an antimalarial drug presented as infant co-formulation of two separate drugs
Other Name: Artequin®
Active Comparator: arm 3 : Dihydroartemisinin piperaquine
Dihydroartemisinin piperaquine (DHA-PQ ) is an antimalaria drug administered as a combination of dihydroartemisinin, 2.5 mg per kg, with piperaquine phosphate, 20mg per kg daily for 3 days or three times, at an interval of 24 hours
Drug: Dihydroartemisinin piperaquine
Malacur®. is an antimalarial drug presentad as co-formulation of two separate drugs
Other Name: Malacur®
Oral paracetamol is administered at of 50mg/kg body weight per day in three divided doses for fever exceeding 37.5oC.
Paracetamol, is an antipyretic drug, presented as tablets or syrup in infants formulation
Other Name: Paracetamol syrup
amoxicillin is an antibiotic administered at 50mg per kg body weight per day for seven days in the event of concomitant bacterial infection, absent on day 0 but present during the follow up.
Amoxicillin is an antibiotic with no reported activity on plasmodium
Other Name: Clamoxyl® 125 mg/5mL
Quinine is an antimalarial recommended by the WHO and NMCP to be used as second line treatment for malaria. In this study, for cases of treatment failure with the artemisinin based combination therapies, quinine sulphate is administered as a second line or rescue drug at a dose of 25mg base per kg body weight per day in three divided doses for five days. The participant is then classified as ETF or LTF and excluded from the study.
quinine sulphate is an antimalaria drug administered as a second line or rescue drug
Other Name: Quinine sulphate
- efficacy and safety assessment [ Time Frame: 42 days ]The primary endpoint was the 28-day and 42-day cure rates and was defined as proportion of patients with adequate clinical and parasitological response (ACPR) after 28 and 42 days of follow-up. Absence of parasitemia until day 28 and day 42 irrespective of axillary temperature was categorized as an adequate clinical and parasitologic response (ACPR). Secondary endpoints were early treatment failure (ETF), late clinical failure (LCF), late parasitological failure (LPF), adverse events (clinical and laboratory abnormalities), anaemia (Hematocrit < 30%), clearance rate of fever and parasitaemia, and gametocyte
- Hemoglobin level [ Time Frame: 42 days follow-up ]The ability of the drug to restore hemoglobin level back to normal
- parasite clearance rate assessment [ Time Frame: 42 days ]The ability of the drug to completely eliminate plasmodium in the blood stream including participant without symptoms of fever
- PCR-correction [ Time Frame: 42 days ]blood sample from patients with parasitaemia at any day of follow-up are analysed by PCR to evaluated the genetic profile of the MSP1 and MSP2
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|Ages Eligible for Study:||6 Months to 59 Months (Child)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- signs/symptoms of uncomplicated malaria with axillary temperature ≥ 37.5;
- monoinfection with Plasmodium falciparum;
- parasite count between 2000 and 200 000 per μl;
- haemoglobin level> 5 g/dL;
- absence of signs/symptoms of severe malaria or other diseases requiring drugs with antimalaria or antihistaminic activities;
- parent/guardian willingness to give their consent
- Chronic disease (HIV, malnutrition etc.),
- severe anaemia (haemoglobin level< 5 g/dL),
- respiratory distress, inability to drink, convulsion etc.,
- history of intolerance to test drugs;
- co-infection requiring drug with antihistaminic or antimalaria activities such as cotrimozaxole
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02974348
|Tiko, South west, Cameroon, 237|
|Study Director:||Xiaonong Zhou, PhD||National Institute for Parasitic Disease|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||University of Bamenda|
|Other Study ID Numbers:||
|First Posted:||November 28, 2016 Key Record Dates|
|Last Update Posted:||November 29, 2016|
|Last Verified:||November 2016|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
Vector Borne Diseases
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs