Epidemiology Study of Malaria Transmission Intensity in Sub-Saharan Africa

Malaria Clinical Trial

Official title:

Epidemiology Study of Malariometric Determinants in Selected Post-Approval Programme Study Sites in Sub-Saharan Western Africa

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01954264
• Other study ID #: 200187
• Status: Completed
• Phase: N/A
• Start date: October 19, 2013
• Est. completion date: November 25, 2013

Study information

• Verified date: January 2020
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2421
• Est. completion date: November 25, 2013
• Est. primary completion date: November 22, 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 9 Years

Eligibility

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.

Related Conditions & MeSH terms

• Malaria

Intervention

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

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

Locations

Country	Name	City	State
Burkina Faso	GSK Investigational Site	Nouna
Burkina Faso	GSK Investigational Site	Ouagadougou
Senegal	GSK Investigational Site	Dakar

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

Burkina Faso,  Senegal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
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	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)
Primary	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	Number of Subjects With Other Medical History Characteristics, Overall	The medical history characteristics were as follows: -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).	At Epoch 1 (Survey visit) (approximately 35 days)
Secondary	Number of Subjects by Age, According to P. Falciparum Infection Status	The annual age extended over a 0 year-9 years range. The age characteristics were summarized by P. falciparum infection status.	At Epoch 1 (Survey visit) (approximately 35 days)
Secondary	Number of Subjects by JTEG Age Group, According to P. Falciparum Infection Status	The JTEG categorisation referred to the distribution of subjects by different age groups: 6 months to 4 years of age inclusive (0.5Y-4Y category) and 5 to 9 years of age inclusive (5-9Y category), tabulated according to P. falciparum infection status.	At Epoch 1 (Survey visit) (approximately 35 days)
Secondary	Number of Subjects by Gender, According to P. Falciparum Infection Status	The gender characteristics were summarized by P. falciparum infection status.	At Epoch 1 (Survey visit) (approximately 35 days)
Secondary	Number of Subjects With Plasmodium Species Other Than P. Falciparum, by JTEG Age Group and Per Total Centers	Other Plasmodium species included: P. Malariae, P. Vivax, P. Ovale with Negative and Positive results. A subjects was defined as infected by a specified parasitemia if at least two of the subject`s blood slide readings were positive for the corresponding parasitemia. The results were tabulated according to JTEG age categorisation.	At Epoch 1 (Survey visit) (approximately 35 days)
Secondary	Number of Subjects With Anti-malarial Therapy, Overall	Anti-malarial therapy included Malaria treatment (MT) in past 14 days, Other medication (OM) in past 14 days and Malaria hospitalization (MH) in the last 3 months.	At Epoch 1 (Survey visit) (approximately 35 days)
Secondary	Number of Days With Therapy, Overall	The duration of anti-malarial therapy referred to the exact number of days of malaria treatment (EDMT) and the number of days of other medication (DOM). Note: * In case of several medication (malaria treatment or other medication) taken per subject, the maximum duration was computed for this study.	At Epoch 1 (Survey visit) (approximately 35 days)
Secondary	Days of Malaria Treatment, Overall	This endpoint presents results per total centers and across all age categories.	At Epoch 1 (Survey visit) (approximately 35 days)
Secondary	Number of Subjects With Fever, Overall	Characteristics of fever were the following: Fever in the last 24 hours (F 24h) and Fever* at visit (F* at V). Note: *Fever set to Yes if temperature recorded at visit after axillary conversion was = 37.5 ?C.	At Epoch 1 (Survey visit) (approximately 35 days)
Secondary	Days With Fever, Overall	This endpoint presents results per total centers and across all age categories.	At Epoch 1 (Survey visit) (approximately 35 days)
Secondary	Number of Persons With P. Falciparum Living in the Same Part of the House of Persons Enrolled in the Study (PLSPH-PES), Overall	The malaria prevention and risk factor presented in this endpoint was: Number of persons living in the same part of the house - persons enrolled in the study (PLSPH-PES), in the following combinations: < y/x, where x are persons enrolled in the study among less than y persons living in the same part of the house, y-z/x, where x are persons enrolled in the study among y to z persons living in the same part of the house, > z/x, where x persons are enrolled in the study among more than z persons living in the same part of the house, y-z/> x, where more than x persons enrolled in the study among y to z persons living in the same part of the house, > z/> x, where more than x persons enrolled in the study among more than z persons living in the same part of the house.	At Epoch 1 (Survey visit) (approximately 35 days)
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	The malaria prevention and risk factor presented in this endpoint was: Number of persons living in the same part of the house (PLSPH).	At Epoch 1 (Survey visit) (approximately 35 days)
Secondary	Number of Subjects With Different P. Falciparum Parasite Densities, Living in the Same House, by Center	The malaria prevention and risk factor for this endpoint was: Number of subjects living in the same part of the house - persons enrolled in the study (PLSPH-PES), in the following combinations: < y/x, where x are persons enrolled in the study among less than y persons living in the same part of the house, y-z/x, where x are persons enrolled in the study among y to z persons living in the same part of the house, > z/x, where x persons are enrolled in the study among more than z persons living in the same part of the house, y-z/> x, where more than x persons enrolled in the study among y to z persons living in the same part of the house, > z/> x, where more than x persons enrolled in the study among more than z persons living in the same part of the house. Results are presented for the Nouna-Burkina Faso (NOU-BF), Ouagadougou-Burkina Faso (OUA-BF), Keur Soce [Dakar area)-Senegal (DA-1-SE) and Naikhar (Dakar area)-Senegal (DA-2-SE) centers.	At Epoch 1 (Survey visit) (approximately 35 days)
Secondary	Descriptive Statistics for Subjects With Different P. Falciparum Parasite Densities, Living in the Same House, by Center	The malaria prevention and risk factor for this endpoint was: Number of subjects living in the same part of the house (PLSPH). Results are presented for the Nouna-Burkina Faso (NOU-BF), Ouagadougou-Burkina Faso (OUA-BF), Keur Soce [Dakar area)-Senegal (DA-1-SE) and Naikhar (Dakar area)-Senegal (DA-2-SE) centers.	At Epoch 1 (Survey visit) (approximately 35 days)
Secondary	Number of Subjects With P. Falciparum by Situation Area, Overall	The malaria prevention and risk factor characteristics for this endpoint were the following: Situation area (rural, urban, semi-rural) and Type of Location*. Note: *Large city = >1 million habitants; Small city = >50000 & < 1 million habitants ; Town = > 10000 and < 50000 habitants; Countryside = < 10000 habitants.	At Epoch 1 (Survey visit) (approximately 35 days)
Secondary	Number of Subjects With Different P. Falciparum Densities by Situation Area and Center	The malaria prevention and risk factor characteristics were the following: Situation area (urban, rural, semi-rural) and Type of Location*. Note: *Large city = >1 million habitants; Small city = >50000 & < 1 million habitants ; Town = > 10000 and < 50000 habitants; Countryside = < 10000 habitants. Results are presented for the Nouna-Burkina Faso (NOU-BF), Ouagadougou-Burkina Faso (OUA-BF), Keur Soce [Dakar area)-Senegal (DA-1-SE) and Naikhar (Dakar area)-Senegal (DA-2-SE) centers.	At Epoch 1 (Survey visit) (approximately 35 days)
Secondary	Number of Subjects With P. Falciparum by House Construction Material and Other House Information, Overall	The malaria prevention and risk factor characteristics for this endpoint were the following: - Main house construction material (MHCM) walls, floor, roof, windows/eaves, nets; - Main source of drinking water (MSDW); - Presence of electricity (PE). Note: *Natural floor = earth, sand, dung; Rudimentary floor = wood planks, palm, bamboo. % Closed water source (piper water, tube well, dug well, protected well); Open water source (unprotected well, spring water, rainwater, tanker truck, surface water).	At Epoch 1 (Survey visit) (approximately 35 days)
Secondary	Number of Subjects With Different P. Falciparum Parasite Densities, by House Information and Center	The malaria prevention and risk factor characteristics for this endpoint were the following: - Main house construction material (MHCM) walls, floor, roof, windows/eaves, nets; - Main source of drinking water (MSDW); - Presence of electricity (PE). Natural floor = earth, sand, dung; Rudimentary floor = wood planks, palm, bamboo. Closed water source = pipe water, tube well, dug well, protected well; Open water source = unprotected well, spring water, rainwater, tanker truck, surface water. Results are presented for the Nouna-Burkina Faso (NOU-BF), Ouagadougou-Burkina Faso (OUA-BF), Keur Soce [Dakar area)-Senegal (DA-1-SE) and Naikhar (Dakar area)-Senegal (DA-2-SE) centers.	At Epoch 1 (Survey visit) (approximately 35 days)

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