Clinical trial NCT01954264: Epidemiology Study of Malaria Transmission Intensity in Sub-Saharan Africa
Official title: Epidemiology Study of Malariometric Determinants in Selected Post-Approval Programme Study Sites in Sub-Saharan Western Africa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malaria
Keywords: Saharan Western Africa
Epidemiology
Post-Approval Programme study
Malaria
Burden of Disease Study
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2013-10-01
Enrollment: 2421
Sex: ALL
Minimum age (years): 6
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study is designed to characterise P. falciparum transmission intensity in subjects aged ≥6 months and \<10 years by measurement of P. falciparum parasite prevalence, and to estimate the use of malaria control interventions at some centres selected for the EPI-MAL-002 and EPI-MAL-003 studies in sub-Saharan Western Africa.

Detailed description: Two subsequent studies (EPI-MAL-002 and EPI-MAL-003) are planned to monitor vaccine safety prior to and after implementation of the RTS,S/AS01 candidate malaria vaccine. EPI-MAL-002 will take place before RTS,S is authorised and EPI-MAL-003 will start when RTS,S is registered and authorised in the country. A cross-sectional survey at peak transmission will provide by-site point estimates of Parasite prevalence (PP) and malaria control measure coverage in the areas participating in EPI-MAL-002/-003. EPI-MAL-006 will be conducted in advance of EPI-MAL-002/-003 in order to assess PP and malaria control measures to inform enrollment in these studies. The age group for enrollment (≥6 months - \<10 years) will permit analysis of PP according to the World Health Organization (WHO) definition (2-9 years) and by the Joint Technical Expert Group (JTEG) suggested age (\<5 years).

Eligibility criteria: Inclusion Criteria:

* Subjects' parent(s)/Legally Acceptable Representative(s) \[LAR(s)\] who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
* A male or female equal or more than 6 months of age and less than 10 years of age at the time of survey.
* Signed informed consent or thumb-printed and witnessed informed consent obtained from the parent(s)/LAR(s) of the child.

Exclusion Criteria:

* Child in care.
* Current active participation in any trial involving administration of an investigational malaria vaccine or malaria drug.

Primary outcomes:
measure: Number of Subjects With Plasmodium Falciparum (P. Falciparum) Parasitaemia (PFP), by Study Center
timeFrame: At Epoch 1 (Survey visit) (approximately 35 days)
measure: Number of Subjects With Malaria Control Interventions (MCIs), Overall
timeFrame: At Epoch 1 (Survey visit) (approximately 35 days)
measure: Number of Subjects Infected With P.Falciparum Parasitemia Receiving Malaria Control Interventions (MCIs), by Infection Status
timeFrame: At Epoch 1 (Survey visit) (approximately 35 days)
measure: Odds Ratio (OR) for the Number of Subjects With MCI, Infected With P. Falciparum Parasitemia, for the Nouna Center in Burkina Faso
timeFrame: At Epoch 1 (Survey visit) (approximately 35 days)
measure: Odds Ratio for the Number of Subjects With MCI, Infected With P. Falciparum Parasitemia, for the Ouagadougu Center in Burkina Faso
timeFrame: At Epoch 1 (Survey visit) (approximately 35 days)
measure: Odds Ratio for the Number of Subjects With MCI, Infected With P. Falciparum Parasitemia, for the Keur Soce Center in Dakar Area in Senegal
timeFrame: At Epoch 1 (Survey visit) (approximately 35 days)
measure: Odds Ratio for the Number of Subjects With MCI, Infected With P. Falciparum Parasitemia, for the Niakhar Center in Dakar Area in Senegal
timeFrame: At Epoch 1 (Survey visit) (approximately 35 days)
Secondary outcomes:
measure: Number of Subjects With Other Medical History Characteristics, Overall
timeFrame: At Epoch 1 (Survey visit) (approximately 35 days)
measure: Number of Subjects by Age, According to P. Falciparum Infection Status
timeFrame: At Epoch 1 (Survey visit) (approximately 35 days)
measure: Number of Subjects by JTEG Age Group, According to P. Falciparum Infection Status
timeFrame: At Epoch 1 (Survey visit) (approximately 35 days)
measure: Number of Subjects by Gender, According to P. Falciparum Infection Status
timeFrame: At Epoch 1 (Survey visit) (approximately 35 days)
measure: Number of Subjects With Plasmodium Species Other Than P. Falciparum, by JTEG Age Group and Per Total Centers
timeFrame: At Epoch 1 (Survey visit) (approximately 35 days)
measure: Number of Subjects With Anti-malarial Therapy, Overall
timeFrame: At Epoch 1 (Survey visit) (approximately 35 days)
measure: Number of Days With Therapy, Overall
timeFrame: At Epoch 1 (Survey visit) (approximately 35 days)
measure: Days of Malaria Treatment, Overall
timeFrame: At Epoch 1 (Survey visit) (approximately 35 days)
measure: Number of Subjects With Fever, Overall
timeFrame: At Epoch 1 (Survey visit) (approximately 35 days)
measure: Days With Fever, Overall
timeFrame: At Epoch 1 (Survey visit) (approximately 35 days)
measure: Number of Persons With P. Falciparum Living in the Same Part of the House of Persons Enrolled in the Study (PLSPH-PES), Overall
timeFrame: At Epoch 1 (Survey visit) (approximately 35 days)
measure: Descriptive Statistics for Number of Persons With P. Falciparum Living in the Same Part of the House of Persons Enrolled in the Study (PLSPH-PES), Overall
timeFrame: At Epoch 1 (Survey visit) (approximately 35 days)
measure: Number of Subjects With Different P. Falciparum Parasite Densities, Living in the Same House, by Center
timeFrame: At Epoch 1 (Survey visit) (approximately 35 days)
measure: Descriptive Statistics for Subjects With Different P. Falciparum Parasite Densities, Living in the Same House, by Center
timeFrame: At Epoch 1 (Survey visit) (approximately 35 days)
measure: Number of Subjects With P. Falciparum by Situation Area, Overall
timeFrame: At Epoch 1 (Survey visit) (approximately 35 days)
measure: Number of Subjects With Different P. Falciparum Densities by Situation Area and Center
timeFrame: At Epoch 1 (Survey visit) (approximately 35 days)
measure: Number of Subjects With P. Falciparum by House Construction Material and Other House Information, Overall
timeFrame: At Epoch 1 (Survey visit) (approximately 35 days)
measure: Number of Subjects With Different P. Falciparum Parasite Densities, by House Information and Center
timeFrame: At Epoch 1 (Survey visit) (approximately 35 days)
Other outcomes:
Locations:
city: Nouna
country: Burkina Faso
facility: GSK Investigational Site
city: Ouagadougou
country: Burkina Faso
facility: GSK Investigational Site
city: Dakar
country: Senegal
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Diallo A, Sie A, Sirima S, Sylla K, Ndiaye M, Bountogo M, Ouedraogo E, Tine R, Ndiaye A, Coulibaly B, Ouedraogo A, Faye B, Ba EH, Compaore G, Tiono A, Sokhna C, Ye M, Diarra A, Bahmanyar ER, De Boer M, Pircon JY, Usuf EA. An epidemiological study to assess Plasmodium falciparum parasite prevalence and malaria control measures in Burkina Faso and Senegal. Malar J. 2017 Feb 6;16(1):63. doi: 10.1186/s12936-017-1715-1.