This study assessed the impact of the systematic detection by Rapid Diagnostic Test (RDT) and treatment of asymptomatic carriers of malaria parasites (P. falciparum) with COA566 on the number of clinical malaria cases in children less than 5 years of age and the improvement of hemoglobin levels in the overall population. MedDRA version: 18.1 Level: PT Classification code 10025487 Term: Malaria System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: Riamet
Product Name: Riamet
Product Code: COA566
Pharmaceutical Form: Dispersible tablet
INN or Proposed INN: ARTEMETHER
CAS Number: 71963-77-4
Current Sponsor code: COA566
Concentration
Sponsors
Novartis Pharma AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Subjects who were diagnosed as Asymptomatic Carrier (AC) by Rapid Diagnostic Test (RDT). •Subjects who were diagnosed with a Symptomatic malaria episode, RDT-confirmed (SMRC) Are the trial subjects under 18? yes Number of subjects for this age range: 14000 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 6800 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 950
Exclusion criteria
Exclusion criteria: •Body weight <5 kg. •Hypersensitivity to artemether-lumefantrine or to any of the excipients of the tablets or dispersible tablets. •Presence of severe malaria signs and symptoms •First trimester of pregnancy. •Family history of congenital prolongation of the QTc interval or sudden death or with any other clinical condition known to prolong the QTc interval such as history of symptomatic cardiac arrhythmias, with clinically relevant bradycardia or with severe cardiac disease. •Taking drugs that are known to influence cardiac function and to prolong QTc interval, such as class IA and III: neuroleptics, antidepressant agents, certain antibiotics including some agents of the following classes: macrolides, fluoroquinolones, imidazole and triazole antifungal agents, certain non-sedating antihistamines. •Known disturbances of electrolyte balance, e.g. hypokalemia or hypomagnesemia. •Taking drugs which may be metabolized by cytochrome enzyme CYP2D6
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To evaluate at the community level whether treatment of AC of P falciparum is associated with a lower number of symptomatic malaria episodes RDT confirmed (SMRCs) per person-year over a 12 month follow-up in the infant and children population (i.e. 6 months of age in the intervention versus the control arms.;Secondary Objective: • To assess and compare the prevalence of microscopy confirmed gametocyte carriers (GC) at CSC 4 in the intervention versus the control arm. • To assess and compare the prevalence of microscopy confirmed AC of P. falciparum at CSC 4 in the intervention versus the control arm. • To assess and compare the average cluster hemoglobin levels at end of study (CSC 4) in children (aged > 6 months up to < 5 years) in the intervention versus the control arm.;Primary end point(s): The first primary variable is the number of SMRCs per person-year in the infant and children (i.e. <5 years of age) population of a cluster over a 12 month follow-up. All children <5 years of age from all eligible randomized clusters will be included.;Timepoint(s) of evaluation of this end point: 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The second primary variable is the change in hemoglobin levels from Day 1 to day 28 of CSC 1 in the asymptomatic carriers at CSC 1 analysis set.;Timepoint(s) of evaluation of this end point: 28 days | — |
Countries
Burkina Faso
Contacts
Public ContactClinical Trial Information Desk
Novartis Pharma AG
Outcome results
None listed