A Community Setting Study of Malaria After Systematic Treatment of Asymptomatic Carriers of P. Falciparum With AL/ AL Dispersible - Full Text View

Purpose

This study will assess the impact of the systematic detection by rapid diagnostic test (RDT) and treatment of asymptomatic carriers of malaria parasites (P. falciparum) with AL (or AL dispersible) 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.

Condition	Intervention	Phase
P Falciparum Asymptomatic Carriers	Drug: AL/AL dispersible or alternative treatment as per National Malaria Treatment Guidelines. Drug: Systematic screening of subsample of study arm population without treatment	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Cluster Randomized, Single-centre, Controlled, Parallel, 12-month Prospective Study in Africa of Malaria Incidence in a Community Setting Following Systematic Treatment of Plasmodium Falciparum (P. Falciparum) Asymptomatic Carriers With Artemether-lumefantrine /Artemether-lumefantrine Dispersible

Resource links provided by NLM:

MedlinePlus related topics: Malaria

Drug Information available for: Artemether Lumefantrine

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Symptomatic Malaria Episodes, per person year/12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
• To evaluate if treatment of P falciparum AC is associated with a lower number of symptomatic malaria episodes, per person-year over 12 months in the population <5 years (intervention vs. control arm)
Hemoglobin levels after 28 days [ Time Frame: 12 months ] [ Designated as safety issue: No ]
• To evaluate if treatment of P. falciparum AC is associated with an improvement in hemoglobin levels after 28 days (intervention vs. the control arm)

Secondary Outcome Measures:

Microscopy confirmed gametocyte carriers [ Time Frame: 12 month ] [ Designated as safety issue: No ]
To assess and compare the prevalence of microscopy confirmed gametocyte carriers (GC) at end of study in the intervention vs. control arm.
microscopy confirmed P. falciparum AC [ Time Frame: 12 months ] [ Designated as safety issue: No ]
To assess and compare the prevalence of microscopy confirmed P. falciparum AC of at end of study in the intervention vs. control arm.
average cluster hemoglobin level [ Time Frame: 12 months ] [ Designated as safety issue: No ]
To assess and compare the average cluster hemoglobin levels at end of study in children (aged > 6 months up to < 5 years) in the intervention versus the control arm.
incidence of hospitalization [ Time Frame: 12 months ] [ Designated as safety issue: No ]
To assess and compare the incidence of hospitalization (overall and in the population <5 years) overall and for symptomatic malaria episodes specifically over 12 months' follow up in the intervention versus the control arm
adverse events [ Time Frame: 12 months ] [ Designated as safety issue: No ]
• Assess adverse events up to Day 7 after treatment initiation and serious adverse events up to Day 30 in AL treated patients with RDT confirmed symptomatic malaria

Enrollment:	13600
Study Start Date:	November 2010
Primary Completion Date:	February 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
No Intervention: Control Arm	Drug: AL/AL dispersible or alternative treatment as per National Malaria Treatment Guidelines. Intervention arm Other Name: systematic screening of entire study arm population followed by treatment Drug: Systematic screening of subsample of study arm population without treatment Control
Experimental: Intervention Arm Systematic screening of subsample of study arm population without treatment	Drug: AL/AL dispersible or alternative treatment as per National Malaria Treatment Guidelines. Intervention arm Other Name: systematic screening of entire study arm population followed by treatment Drug: Systematic screening of subsample of study arm population without treatment Control

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

All cluster inhabitants from the selected villages are invited to take part in the study. As this is a community based study, there are no inclusion criteria.

Exclusion Criteria:

There are no study specific exclusion criteria for study entry; however, a subject with a contra-indication to AL (or AL dispersible) will receive alternative treatment as per National Malaria Treatment Guidelines.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01256658

Locations

Burkina Faso
Centre National de Recherche et de Formation sur le Paludisme
Ouagadougou, Burkina Faso

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

Publications:

Ogutu B, Tiono AB, Makanga M, Premji Z, Gbadoé 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.

Responsible Party:	Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:	NCT01256658 History of Changes
Other Study ID Numbers:	CCOA566B2401
Study First Received:	December 6, 2010
Last Updated:	April 23, 2012
Health Authority:	1- Switzerland: EKBB - Ethics Committee from Basel, Switzerland 2- Burkina Faso: CNERS - National Ethics Committee of Burkina Faso 3- Burkina Faso: CIB - Institutional Ethics Committee of CNRFP, Burkina Faso

Keywords provided by Novartis:

P. falciparum, malaria, asymptomatic carriers, bed-nets, ITN, RDTs

Additional relevant MeSH terms:

Malaria
Protozoan Infections
Parasitic Diseases
Artemether-lumefantrine combination
Antimalarials

Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013