Epidemiology Study of Malaria Transmission Intensity in Sub-Saharan Africa

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01954264
• Date of registration: 19/09/2013
• Prospective Registration: Yes
• Primary sponsor: GlaxoSmithKline
• Public title: Epidemiology Study of Malaria Transmission Intensity in Sub-Saharan Africa
• Scientific title: Epidemiology Study of Malariometric Determinants in Selected Post-Approval Programme Study Sites in Sub-Saharan Western Africa
• Date of first enrolment: October 19, 2013
• Target sample size: 2421
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01954264
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Other. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Burkina Faso, Senegal

Contacts

• Name: GSK Clinical Trials
• Affiliation: GlaxoSmithKline

Key inclusion & exclusion 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.



Age minimum: 6 Months
Age maximum: 9 Years
Gender: All

Health Condition(s) or Problem(s) studied

Malaria

Intervention(s)

Procedure: Capillary blood sample

Other: Data collection

Primary Outcome(s)

Number of Subjects With Plasmodium Falciparum (P. Falciparum) Parasitaemia (PFP), by Study Center [Time Frame: At Epoch 1 (Survey visit) (approximately 35 days)]

Odds Ratio for the Number of Subjects With MCI, Infected With P. Falciparum Parasitemia, for the Ouagadougu Center in Burkina Faso [Time Frame: At Epoch 1 (Survey visit) (approximately 35 days)]

Odds Ratio (OR) for the Number of Subjects With MCI, Infected With P. Falciparum Parasitemia, for the Nouna Center in Burkina Faso [Time Frame: At Epoch 1 (Survey visit) (approximately 35 days)]

Odds Ratio for the Number of Subjects With MCI, Infected With P. Falciparum Parasitemia, for the Keur Soce Center in Dakar Area in Senegal [Time Frame: At Epoch 1 (Survey visit) (approximately 35 days)]

Odds Ratio for the Number of Subjects With MCI, Infected With P. Falciparum Parasitemia, for the Niakhar Center in Dakar Area in Senegal [Time Frame: At Epoch 1 (Survey visit) (approximately 35 days)]

Number of Subjects With Malaria Control Interventions (MCIs), Overall [Time Frame: At Epoch 1 (Survey visit) (approximately 35 days)]

Number of Subjects Infected With P.Falciparum Parasitemia Receiving Malaria Control Interventions (MCIs), by Infection Status [Time Frame: At Epoch 1 (Survey visit) (approximately 35 days)]

Secondary Outcome(s)

Days of Malaria Treatment, Overall [Time Frame: At Epoch 1 (Survey visit) (approximately 35 days)]

Number of Days With Therapy, Overall [Time Frame: At Epoch 1 (Survey visit) (approximately 35 days)]

Number of Subjects With Different P. Falciparum Parasite Densities, Living in the Same House, by Center [Time Frame: At Epoch 1 (Survey visit) (approximately 35 days)]

Number of Subjects With Different P. Falciparum Parasite Densities, by House Information and Center [Time Frame: At Epoch 1 (Survey visit) (approximately 35 days)]

Number of Subjects With Other Medical History Characteristics, Overall [Time Frame: At Epoch 1 (Survey visit) (approximately 35 days)]

Number of Subjects With Plasmodium Species Other Than P. Falciparum, by JTEG Age Group and Per Total Centers [Time Frame: At Epoch 1 (Survey visit) (approximately 35 days)]

Number of Persons With P. Falciparum Living in the Same Part of the House of Persons Enrolled in the Study (PLSPH-PES), Overall [Time Frame: At Epoch 1 (Survey visit) (approximately 35 days)]

Number of Subjects by Gender, According to P. Falciparum Infection Status [Time Frame: At Epoch 1 (Survey visit) (approximately 35 days)]

Days With Fever, Overall [Time Frame: At Epoch 1 (Survey visit) (approximately 35 days)]

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 [Time Frame: At Epoch 1 (Survey visit) (approximately 35 days)]

Descriptive Statistics for Subjects With Different P. Falciparum Parasite Densities, Living in the Same House, by Center [Time Frame: At Epoch 1 (Survey visit) (approximately 35 days)]

Number of Subjects by JTEG Age Group, According to P. Falciparum Infection Status [Time Frame: At Epoch 1 (Survey visit) (approximately 35 days)]

Number of Subjects With P. Falciparum by House Construction Material and Other House Information, Overall [Time Frame: At Epoch 1 (Survey visit) (approximately 35 days)]

Number of Subjects With P. Falciparum by Situation Area, Overall [Time Frame: At Epoch 1 (Survey visit) (approximately 35 days)]

Number of Subjects With Fever, Overall [Time Frame: At Epoch 1 (Survey visit) (approximately 35 days)]

Number of Subjects by Age, According to P. Falciparum Infection Status [Time Frame: At Epoch 1 (Survey visit) (approximately 35 days)]

Number of Subjects With Anti-malarial Therapy, Overall [Time Frame: At Epoch 1 (Survey visit) (approximately 35 days)]

Number of Subjects With Different P. Falciparum Densities by Situation Area and Center [Time Frame: At Epoch 1 (Survey visit) (approximately 35 days)]

Secondary ID(s)

200187

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 05/10/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01954264