A Community Setting Study of Malaria After Systematic Treatment of Symptomatic Carriers of P. Falciparum With COA566 (Coartem®)

NCT01256658 | Completed Phase 4 Results

• 2 other identifiers: CCOA566B2401CCOA566B2401E1
• Study Type: interventional
• Target: 14,075
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Malaria

Keywords

P. falciparum; malaria; asymptomatic carriers; bed-nets; ITN-insecticide-treated net; idiopathic trigeminal neuralgia; RDT-Rapid diagnostic test

Outcome Measures

Primary Outcomes (2)

• 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)

  Data is presented "per cluster". 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 was detected by Rapid Diagnostic Test (RDT) (using a blood sample from each participant) and later confirmed to have a parasite density ≥5000/uL by microscopy. Number of SMRC5000: sum of all SMRC5000 for all infants and children (\<5 years) in post CSC. Person-year observed: sum of duration (in days) for all infants and children (\<5 years) in post CSC present in study /365.25. Number of SMRC5000 per person-year = number of SMRC5000/person-year observed.

  Month 12 of period 1

• Change in Hemoglobin Level (g/dL) in Asymptomatic Carriers >6 Months of Age (Per Cluster)

  Data is presented "per cluster". Change in hemoglobin levels from day 1 to day 28 was measured using the HemoCue® rapid test. This test was performed using a drop of blood collected from the fingertip of each asymptomatic carrier from Community Screening Campaign 1 (CSC1), \> 6 months of age, at day 1 and at day 28.

  Day 1 and day 28 of period 1

Secondary Outcomes (20)

• Microscopy-confirmed Gametocyte Carriers at Community Screening Campaign 4 (CSC4) (Per Cluster)

  Month 12 - period 1

• Microscopy Confirmed Asymptomatic Carriers of P. Falciparum at Community Screening Campaign 4 (CSC4) (Per Cluster)

  Month 12 - period 1

• Change in Hemoglobin Level (g/dL) From Community Screening Campaign 1(CSC1)/Day 1 to Community Screening Campaign 4 (CSC4)/Day 1 (Per Cluster)

  Day 1 (CSC1/day 1) and month 12 (CSC4/day 1) - period 1

• Number of Symptomatic Malaria Episode, RDT-confirmed, With Parasitemia ≥5000/μL (SMRC5000s) Per Person-year in Post Community Screening Campaign (CSC)

  12 months - period 1

• Number of Participants With Hospitalizations, Severe Malaria Episodes or Death Post Community Screening Campaign (CSC)

  12 months - period 1

Study Arms (2)

Intervention

EXPERIMENTAL

Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.

Drug: COA566

Control

EXPERIMENTAL

Participants received COA566 treatment for symptomatic malaria episodes only.

Drug: COA566

Interventions

COA566 DRUG

COA566 tablets or dispersible tablets twice daily during 3 days; dosage according to body weight.

Also known as: Artemether-lumefantrine

Control; Intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis: lead

Study Sites (3)

Centre National de Recherche et de Formation sur le Paludisme

Ouagadougou, Ouagadougou, Burkina Faso

Location

Novartis Investigative site

Ouagadougou, Ouagadougou, Burkina Faso

Location

Novartis Investigative Site

Burkina Faso, 2208, Burkina Faso

Location

Related Publications (2)

• Ogutu B, Tiono AB, Makanga M, Premji Z, Gbadoe AD, Ubben D, Marrast AC, Gaye O. Treatment of asymptomatic carriers with artemether-lumefantrine: an opportunity to reduce the burden of malaria? Malar J. 2010 Jan 22;9:30. doi: 10.1186/1475-2875-9-30.

  PMID: 20096111 BACKGROUND

• Tiono AB, Guelbeogo MW, Sagnon NF, Nebie I, Sirima SB, Mukhopadhyay A, Hamed K. Dynamics of malaria transmission and susceptibility to clinical malaria episodes following treatment of Plasmodium falciparum asymptomatic carriers: results of a cluster-randomized study of community-wide screening and treatment, and a parallel entomology study. BMC Infect Dis. 2013 Nov 12;13:535. doi: 10.1186/1471-2334-13-535.

  PMID: 24215306 DERIVED

MeSH Terms

Conditions

Malaria; Trigeminal Neuralgia

Interventions

Artemether, Lumefantrine Drug Combination

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases; Trigeminal Nerve Diseases; Facial Neuralgia; Facial Nerve Diseases; Mouth Diseases; Stomatognathic Diseases; Cranial Nerve Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Artemether; Artemisinins; Reactive Oxygen Species; Free Radicals; Inorganic Chemicals; Organic Chemicals; Lumefantrine; Fluorenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sesquiterpenes; Terpenes; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Results Point of Contact

• Title: Study Director
• Organization: Novartis

41 61 324 1111

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2010
• First Posted: December 8, 2010
• Study Start: November 1, 2010
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: February 10, 2014
• Results First Posted: November 25, 2013

Record last verified: 2013-11

Locations

BU (3)