Phase 4
N=14,075
A Community Setting Study of Malaria After Systematic Treatment of Symptomatic Carriers of P. Falciparum With COA566 (Coartem®)
Malaria
Bottom Line
View on ClinicalTrials.gov: NCT01256658 ↗Enrolled (actual)
14,075
Serious AEs
4.4%
Results posted
Nov 2013
Primary outcome: Primary: Number of Symptomatic Malaria Episode, RDT-confirmed, With Parasitemia ≥5000/μL (SMRC5000s) Per Person-year in Infants and Children (<5 Years) in Post Community Screening Campaign (CSC) at Month 12 (Per Cluster) — 1.69; 1.60 SMRC5000 per person-year
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- COA566 (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Novartis
- Primary completion
- Jul 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Symptomatic Malaria Episode, RDT-confirmed, With Parasitemia ≥5000/μL (SMRC5000s) Per Person-year in Infants and Children (<5 Years) in Post Community Screening Campaign (CSC) at Month 12 (Per Cluster) |
1.69; 1.60 | — |
| PRIMARY Change in Hemoglobin Level (g/dL) in Asymptomatic Carriers >6 Months of Age (Per Cluster) |
11.81; 12.06; 12.33; 11.86 | — |
| SECONDARY Microscopy-confirmed Gametocyte Carriers at Community Screening Campaign 4 (CSC4) (Per Cluster) |
4.9; 5.1 | — |
| SECONDARY Microscopy Confirmed Asymptomatic Carriers of P. Falciparum at Community Screening Campaign 4 (CSC4) (Per Cluster) |
34.6; 37.6 | — |
| SECONDARY Change in Hemoglobin Level (g/dL) From Community Screening Campaign 1(CSC1)/Day 1 to Community Screening Campaign 4 (CSC4)/Day 1 (Per Cluster) |
10.24; 10.04; 10.99; 11.13 | — |
| SECONDARY Number of Symptomatic Malaria Episode, RDT-confirmed, With Parasitemia ≥5000/μL (SMRC5000s) Per Person-year in Post Community Screening Campaign (CSC) |
0.45; 0.39 | — |
| SECONDARY Number of Participants With Hospitalizations, Severe Malaria Episodes or Death Post Community Screening Campaign (CSC) |
68; 57; 10; 9; 31; 31 | — |
| SECONDARY Number of Participants (Infants and Children (> 6 Months and < 5 Years)) With Hospitalizations, Severe Malaria Episodes or Death Post Community Screening Campaign (CSC) |
20; 21; 4; 5; 2; 2 | — |
| SECONDARY Mean of Microscopy-confirmed Asymptomatic Carriers From Community Screening Campaigns 1, 2, 3 and 4 (CSC1, CSC2, CSC3 and CSC4) (Per Cluster) |
42.8; 47.5; 4.1; 35.7; 2.8; 32.2 | — |
| SECONDARY Mean Number of Microscopy-confirmed Gametocyte Carriers at Day 1 of Community Screening Campaign 1,2,3,4 (CSC1, CSC2, CSC3 and CSC4) (Per Cluster) |
9.5; 10.2; 0.6; 5.5; 0.4; 5.8 | — |
| SECONDARY Number of Microscopy and qRT-PCR-confirmed Gametocyte Carriers at Community Screening Campaign 4 (CSC4) |
508; 462; 514; 511; 1; 3 | — |
| SECONDARY Change in Hemoglobin Level (g/dL) From Community Screening Campaign 1 (CSC1)/Day 1 to CSC1/Day 28 in Infants and Children (>6 Months and <5 Years) for Asymptomatic Carriers at CSC1 |
9.78; 9.67; 10.95; 10.17 | — |
| SECONDARY Anemia Status Based on Community Screening Campaign 1 (CSC1)/Day 1 in Infants and Children (>6 Months and <5 Years) |
3; 1; 80; 36; 458; 195 | — |
| SECONDARY Anemia Status Based on Community Screening Campaign 4 (CSC4)/Day 1 in Infants and Children (>6 Months and <5 Years) |
1; 1; 29; 9; 349; 117 | — |
| SECONDARY Hemoglobin Level (g/dL) in Community Screening Campaign 1 (CSC1)/Day 1 and CSC4/Day 1 by Study Arm and Age Group (Per Cluster) |
11.63; 11.59; 11.97; 12.13; 12.32; 12.71 | — |
| SECONDARY Percentage of COA566-treated Microscopy-confirmed Asymptomatic Carriers at Community Screening Campaign 1, 2 and 3 (CSC1, CSC2 and CSC3) With Parasitological Cure Rate at Day 7 |
99.5; 100; 96.7 | — |
| SECONDARY Percentage of Microscopy-confirmed Gametocyte Carriers Treated With COA566 for Asymptomatic Carriers |
15.7; 1.4; 0.1; 2.6; 0.1; 4.0 | — |
| SECONDARY Number of Asymptomatic Carriers With Increase in Hemoglobin Levels by at Least 0.5 g/dL From Community Screening Campaign 1 (CSC1) Infants and Children (>6 Months and <5 Years)- Individual Data |
288; 79 | — |
| SECONDARY Number of Asymptomatic Carriers With Increase in Hemoglobin Levels by at Least 0.5 g/dL From Day 1 to Day 28 of Community Screening Campaign 1 (CSC1) in Infants and Children (>6 Months and <5 Years)- Cluster Data |
66.1; 43.2 | — |
| SECONDARY Number of Symptomatic Malaria Episode, RDT-confirmed, With Parasitemia ≥5000/μL (SMRC5000) in Asymptomatic Carriers at Any Time of Diagnosis (Per Cluster) |
15.25; 9.49; 3.56; 2.78; 1.28; 0.97 | — |
| SECONDARY Number of Asymptomatic Carriers With Complicated and Uncomplicated Episodes Combined |
413; 136; 96; 38; 34; 12 | — |
| SECONDARY Cumulative Number of Subjects With Symptomatic Malaria Episode, RDT-confirmed, With Parasitemia ≥5000/μL From Week 1 to Week 50 |
1; 4; 3; 8; 4; 12 | — |
Summary
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 a number of clinical malaria cases in children less than 5 years of age and the improvement of hemoglobin levels in the overall population.
Eligibility Criteria
Inclusion:
- 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)
Exclusion:
- 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
Data sourced from ClinicalTrials.gov (NCT01256658). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.