Epidemiology Study of Malaria Transmission Intensity in Sub-Saharan Africa

NCT01954264 | Completed Results

• 1 other identifier: 200187
• Study Type: interventional
• Target: 2,421
• Locations: 2 countries
• Sites: 3

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.

Conditions

Malaria

Keywords

Saharan Western Africa; Epidemiology; Post-Approval Programme study; Malaria; Burden of Disease Study

Outcome Measures

Primary Outcomes (7)

• Number of Subjects With Plasmodium Falciparum (P. Falciparum) Parasitaemia (PFP), by Study Center

  PFP = measurement of parasite prevalence (PP) by center according to joint technical expert group (JTEG). Centers: Nouna-Burkina Faso (NOU-BF), Ouagadougou-Burkina Faso (OUA-BF), Keur Soce \[Dakar area)-Senegal (DA-1-SE), Naikhar (Dakar area)-Senegal (DA-2-SE). A subject was defined as infected by P. falciparum parasitemia, if at least two of the subject's blood slide readings were positive for the corresponding parasitemia.

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

• Number of Subjects With Malaria Control Interventions (MCIs), Overall

  MCI = measurement of residual spraying, mosquito net usage, seasonal malaria chemoprevention (SMC), intermittent preventative treatment in infants (IPTi) and Artemisinin-based combination therapy (ACT) - therapy received within the last 14 days as indicator of malaria transmission intensity (MTI) by center and JTEG according to P. Falciparum infection status. Centers: Nouna-Burkina Faso (NOU-BF), Ouagadougou-Burkina Faso (OUA-BF), Keur Soce \[Dakar area)-Senegal (DA-1-SE), Naikhar (Dakar area)-Senegal (DA-2-SE). Results presented for overall centers by the following characteristics: Use of Mosquito colis over 7 days (UMc \> 7D), Use of Insecticide spray over 7 days (UIs \> 7D), Use of Commercial Repellents over 7 days (UCR \> 7D), Use of Traditional Repellents over 7 days (UTR \> 7D), Use of none of above over 7 days (Una \>7D), Use of indoor residual spray in past 12 months to spray interior walls (Uirs past 12M), Use of indoor residual spray - number of months ago (Uirs-nM)

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

• Number of Subjects Infected With P.Falciparum Parasitemia Receiving Malaria Control Interventions (MCIs), by Infection Status

  MCI = measurement of residual spraying, mosquito net usage, seasonal malaria chemoprevention (SMC), intermittent preventative treatment in infants (IPTi) and Artemisinin-based combination therapy (ACT) - therapy received within the last 14 days as indicator of malaria transmission intensity (MTI) by center and JTEG according to P. Falciparum infection status. Centers: Nouna-Burkina Faso (NOU-BF), Ouagadougou-Burkina Faso (OUA-BF), Keur Soce \[Dakar area)-Senegal (DA-1-SE), Naikhar (Dakar area)-Senegal (DA-2-SE). Results presented for overall centers by the following characteristics: Use of Mosquito colis over 7 days (UMc \> 7D), Use of Insecticide spray over 7 days (UIs \> 7D), Use of Commercial Repellents over 7 days (UCR \> 7D), Use of Traditional Repellents over 7 days (UTR \> 7D), Use of none of above over 7 days (Una \>7D), Use of indoor residual spray in past 12 months to spray interior walls (Uirs past 12M), Use of indoor residual spray - number of months ago (Uirs-nM)

  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

  MCI = measurement of residual spraying, mosquito net usage, SMC, IPTi and ACT - therapy received within the last 14 days as indicator of MTI according to P. falciparum infection status. Note: - There was only the reference category available for 'Use of Traditional Repellents over 7 days': Missing/No - There was only one category available for 'Use of indoor residual spray - number of month ago': 2 Characteristics were as follows: Malaria treatment in past 14 days (Mt past 14D), Numbers of days of malaria treatment (NdMt), Other medication in the past 14 days (Om past 14D), Number of days of other medication (Ndom), Was the subject hospitalized in the last 3 months due to Malaria (Wsh3MM), Subject sleep under a mosquito net night before visit (Ssumnnbv), New net - less than 1 year (Nn \< 1Y), Impregnated bednet (Ib), Pierced/torn bednet (P/tb), How many holes of that size (HS), UMc \> 7D, UIs \> 7D, UCR \> 7D, UTR \> 7D, Una \>7D, Uirs past 12M.

  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

  MCI = measurement of residual spraying, mosquito net usage, SMC, IPTi and ACT - therapy received within the last 14 days as indicator of MTI according to P. falciparum infection status. Note: - There was only the reference category for 'Use of Insecticide spray over 7 days': Missing/No and 'Use of Traditional Repellents over 7 days': Missing/No - The reference category ('2') for 'Use of indoor residual spray - number of month ago': 2 Characteristics were as follows: Malaria treatment in past 14 days (Mt past 14D), Numbers of days of malaria treatment (NdMt), Other medication in the past 14 days (Om past 14D), Number of days of other medication (Ndom), Was the subject hospitalized in the last 3 months due to Malaria (Wsh3MM), Subject sleep under a mosquito net night before visit (Ssumnnbv), New net - less than 1 year (Nn \< 1Y), Impregnated bednet (Ib), Pierced/torn bednet (P/tb), How many holes of that size (HS), UMc \> 7D, UIs \> 7D, UCR \> 7D, UTR \> 7D, Una \>7D, Uirs past 12M.

  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

  MCI = measurement of residual spraying, mosquito net usage, SMC, IPTi and ACT - therapy received within the last 14 days as indicator of MTI according to P. falciparum infection status. Note: - There was only one category available for 'Exact number of days of malaria treatment':1-3 days, 'Use of Indoor residual spray - numbers of months ago': 9, 'Use of Commercial Repellents over 7 days': Missing/No - There were not enough values in the reference category ('\<5') to compute the OR for HS. Characteristics were as follows: Malaria treatment in past 14 days (Mt past 14D), Other medication in the past 14 days (Om past 14D), Number of days of other medication (Ndom), Was the subject hospitalized in the last 3 months due to Malaria (Wsh3MM), Subject sleep under a mosquito net night before visit (Ssumnnbv), New net - less than 1 year (Nn \< 1Y), Impregnated bednet (Ib), Pierced/torn bednet (P/tb), UMc \> 7D, UIs \>7D, UCR \> 7D, UTR \> 7D, Una \>7D.

  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

  MCI = measurement of residual spraying, mosquito net usage, SMC, IPTi and ACT - therapy received within the last 14 days as indicator of MTI according to P. falciparum infection status. Note: - There was only one category available for 'Exact number of days of malaria treatment':1-3 days and 'How many holes of that size': ≥5. Characteristics were as follows: Malaria treatment in past 14 days (Mt past 14D), Numbers of days of malaria treatment (NdMt), Other medication in the past 14 days (Om past 14D), Number of days of other medication (Ndom), Was the subject hospitalized in the last 3 months due to Malaria (Wsh3MM), Subject sleep under a mosquito net night before visit (Ssumnnbv), New net - less than 1 year (Nn \< 1Y), Impregnated bednet (Ib), Pierced/torn bednet (P/tb), How many holes of that size (HS), UMc \> 7D, UIs \> 7D, UCR \> 7D, UTR \> 7D, Una \>7D, Uirs past 12M.

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

Secondary Outcomes (18)

• Number of Subjects With Other Medical History Characteristics, Overall

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

• Number of Subjects by Age, According to P. Falciparum Infection Status

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

• Number of Subjects by JTEG Age Group, According to P. Falciparum Infection Status

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

• Number of Subjects by Gender, According to P. Falciparum Infection Status

  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

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

Study Arms (1)

Overall Study Group

OTHER

Subjects aged between 6 months to 9 years old, who were infected or not infected with Plasmodium falciparum parasite. Infection status was assessed using a blood smear slide and determined using microscopy.

Procedure: Capillary blood sample; Other: Data collection

Interventions

Capillary blood sample PROCEDURE

Capillary blood sample (up to 200µL) for determination of PP (blood slides).

Overall Study Group

Data collection OTHER

Prospective data collection at the study visit by the internet based Electronic Case Report Form (eCRF)

Overall Study Group

Eligibility Criteria

• Age: 6 Months - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (3)

GSK Investigational Site

Nouna, Burkina Faso

Location

GSK Investigational Site

Ouagadougou, Burkina Faso

Location

GSK Investigational Site

Dakar, Senegal

Location

Related Publications (1)

• 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.

  PMID: 28166794 DERIVED

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Malaria

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2013
• First Posted: October 1, 2013
• Study Start: October 19, 2013
• Primary Completion: November 22, 2013
• Study Completion: November 25, 2013
• Last Updated: January 21, 2020
• Results First Posted: October 5, 2018

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD is available via the Clinical Study Data Request site (click on the link provided below).
• Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

Locations

BU (2); SE (1)