Last updated: 07/17/2024 16:58:27

Epidemiology study of malaria transmission intensity in sub-Saharan Africa

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GSK study ID
200187
See study documents
Clinicaltrials.gov ID
NCT01954264
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Epidemiology study of malariometric determinants in selected Post-Approval Programme study sites in sub-Saharan Western Africa
Trial description: 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.
Primary purpose:
Other
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:

Number of subjects with Plasmodium falciparum (P. falciparum) parasitaemia (PFP), by study center

Timeframe: At Epoch 1 (Survey visit) (approximately 35 days)

Number of subjects with malaria control interventions (MCIs), overall

Timeframe: At Epoch 1 (Survey visit) (approximately 35 days)

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)

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)

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)

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)

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:

Number of subjects with other medical history characteristics, overall

Timeframe: At Epoch 1 (Survey visit) (approximately 35 days)

Number of subjects by age, according to P. falciparum infection status

Timeframe: At Epoch 1 (Survey visit) (approximately 35 days)

Number of subjects by JTEG age group, according to P. falciparum infection status

Timeframe: At Epoch 1 (Survey visit) (approximately 35 days)

Number of subjects by gender, according to P. falciparum infection status

Timeframe: 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

Timeframe: At Epoch 1 (Survey visit) (approximately 35 days)

Number of subjects with anti-malarial therapy, overall

Timeframe: At Epoch 1 (Survey visit) (approximately 35 days)

Number of days with therapy, overall

Timeframe: At Epoch 1 (Survey visit) (approximately 35 days)

Days of malaria treatment, overall

Timeframe: At Epoch 1 (Survey visit) (approximately 35 days)

Number of subjects with fever, overall

Timeframe: At Epoch 1 (Survey visit) (approximately 35 days)

Days with fever, overall

Timeframe: At Epoch 1 (Survey visit) (approximately 35 days)

Number of subjects with P. falciparum living in the same house, overall

Timeframe: At Epoch 1 (Survey visit) (approximately 35 days)

Descriptive statistics for subjects with P. falciparum living in the same house, overall

Timeframe: At Epoch 1 (Survey visit) (approximately 35 days)

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)

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)

Number of subjects with P. falciparum by situation area, overall

Timeframe: At Epoch 1 (Survey visit) (approximately 35 days)

Number of subjects with different P. falciparum densities by situation area and center

Timeframe: At Epoch 1 (Survey visit) (approximately 35 days)

Number of subjects with P. falciparum by house construction material and other house information, overall

Timeframe: At Epoch 1 (Survey visit) (approximately 35 days)

Number of subjects with different P. falciparum parasite densities, by house information and center

Timeframe: At Epoch 1 (Survey visit) (approximately 35 days)

Interventions:
  • Procedure/surgery: Capillary blood sample
  • Other: Data collection
    • Enrollment:
    2421
    Primary completion date:
    2013-22-11
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Malaria
    Product
    SB257049
    Collaborators
    Not applicable
    Study date(s)
    October 2013 to November 2013
    Type
    Interventional
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    6 months - 9 years
    Accepts healthy volunteers
    Yes
    • 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.
    • Child in care.
    • Current active participation in any trial involving administration of an investigational malaria vaccine or malaria drug.
    Inclusion and 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.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    DAKAR, Senegal
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Nouna, Burkina Faso
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Ouagadougou, Burkina Faso
    Status
    Study Complete
    Contact us

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)
    Clinical study report
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2013-22-11
    Actual study completion date
    2013-25-11

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

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