N/A N=2,421 Other

Epidemiology Study of Malaria Transmission Intensity in Sub-Saharan Africa

Malaria

Bottom Line

View on ClinicalTrials.gov: NCT01954264 ↗

Enrolled (actual)

2,421

Serious AEs

0.0%

Results posted

Oct 2018

Primary outcome: Primary: Number of Subjects With Plasmodium Falciparum (P. Falciparum) Parasitaemia (PFP), by Study Center — 235; 153; 167; 141 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Capillary blood sample (Procedure); Data collection (Other)
Age: Pediatric · 0+ yrs
Sex: All
Sponsor: GlaxoSmithKline
Primary completion: Nov 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Subjects With Plasmodium Falciparum (P. Falciparum) Parasitaemia (PFP), by Study Center	235; 153; 167; 141; 2; 1	—
PRIMARY Number of Subjects With Malaria Control Interventions (MCIs), Overall	122; 2299; 65; 2356; 12; 2409	—
PRIMARY Number of Subjects Infected With P.Falciparum Parasitemia Receiving Malaria Control Interventions (MCIs), by Infection Status	39; 83; 15; 50; 4; 8	—
PRIMARY Odds Ratio (OR) for the Number of Subjects With MCI, Infected With P. Falciparum Parasitemia, for the Nouna Center in Burkina Faso	0.323; 0.917; 0.596; 0.563; 1.155; NA	—
PRIMARY Odds Ratio for the Number of Subjects With MCI, Infected With P. Falciparum Parasitemia, for the Ouagadougu Center in Burkina Faso	0.143; NA; 0.341; 0.300; 0.568; NA	—
PRIMARY Odds Ratio for the Number of Subjects With MCI, Infected With P. Falciparum Parasitemia, for the Keur Soce Center in Dakar Area in Senegal	NA; 7.395; NA; NA; NA; 0.948	—
PRIMARY Odds Ratio for the Number of Subjects With MCI, Infected With P. Falciparum Parasitemia, for the Niakhar Center in Dakar Area in Senegal	NA; 2.652; NA; 0.340; NA; NA	—
SECONDARY Number of Subjects With Other Medical History Characteristics, Overall	2023; 398; 1591; 431; 399; 1618	—
SECONDARY Number of Subjects by Age, According to P. Falciparum Infection Status	48; 202; 98; 380; 131; 348	—
SECONDARY Number of Subjects by JTEG Age Group, According to P. Falciparum Infection Status	409; 1205; 298; 509	—
SECONDARY Number of Subjects by Gender, According to P. Falciparum Infection Status	337; 818; 370; 896	—
SECONDARY Number of Subjects With Plasmodium Species Other Than P. Falciparum, by JTEG Age Group and Per Total Centers	23; 32; 1591; 775; 0; 0	—
SECONDARY Number of Subjects With Anti-malarial Therapy, Overall	187; 2234; 419; 2002; 60; 2361	—
SECONDARY Number of Days With Therapy, Overall	26; 155; 3; 2237; 101; 310	—
SECONDARY Days of Malaria Treatment, Overall	3.0	—
SECONDARY Number of Subjects With Fever, Overall	331; 2090; 179; 2241; 1	—
SECONDARY Days With Fever, Overall	3.0	—
SECONDARY Number of Persons With P. Falciparum Living in the Same Part of the House of Persons Enrolled in the Study (PLSPH-PES), Overall	517; 590; 864; 54; 112; 214	—
SECONDARY 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	7.8	—
SECONDARY Number of Subjects With Different P. Falciparum Parasite Densities, Living in the Same House, by Center	85; 34; 14; 11; 68; 86	—
SECONDARY Descriptive Statistics for Subjects With Different P. Falciparum Parasite Densities, Living in the Same House, by Center	4.5; 4.6; 4.2; 4.2; 4.7; 3.8	—
SECONDARY Number of Subjects With P. Falciparum by Situation Area, Overall	2127; 294; 0; 14; 0; 282	—
SECONDARY Number of Subjects With Different P. Falciparum Densities by Situation Area and Center	129; 71; 23; 16; 84; 100	—
SECONDARY Number of Subjects With P. Falciparum by House Construction Material and Other House Information, Overall	1176; 728; 140; 365; 12; 1283	—
SECONDARY Number of Subjects With Different P. Falciparum Parasite Densities, by House Information and Center	49; 18; 4; 6; 52; 174	—

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.

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01954264). 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.