Epidemiology Study of Malariometric Determinants in Selected Post-Approval Programme Study Sites in Sub-Saharan Western Africa
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,421
- 试验地点
- 3
- 主要终点
- Number of Subjects With Plasmodium Falciparum (P. Falciparum) Parasitaemia (PFP), by Study Center
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •Child in care.
- •Current active participation in any trial involving administration of an investigational malaria vaccine or malaria drug.
研究组 & 干预措施
Overall Study Group
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.
干预措施: Capillary blood sample (Procedure)
Overall Study Group
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.
干预措施: Data collection (Other)
结局指标
主要结局
Number of Subjects With Plasmodium Falciparum (P. Falciparum) Parasitaemia (PFP), by Study Center
时间窗: At Epoch 1 (Survey visit) (approximately 35 days)
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.
Number of Subjects With Malaria Control Interventions (MCIs), Overall
时间窗: At Epoch 1 (Survey visit) (approximately 35 days)
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)
Number of Subjects Infected With P.Falciparum Parasitemia Receiving Malaria Control Interventions (MCIs), by Infection Status
时间窗: At Epoch 1 (Survey visit) (approximately 35 days)
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)
Odds Ratio (OR) for the Number of Subjects With MCI, Infected With P. Falciparum Parasitemia, for the Nouna Center in Burkina Faso
时间窗: At Epoch 1 (Survey visit) (approximately 35 days)
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.
Odds Ratio for the Number of Subjects With MCI, Infected With P. Falciparum Parasitemia, for the Ouagadougu Center in Burkina Faso
时间窗: At Epoch 1 (Survey visit) (approximately 35 days)
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.
Odds Ratio for the Number of Subjects With MCI, Infected With P. Falciparum Parasitemia, for the Keur Soce Center in Dakar Area in Senegal
时间窗: At Epoch 1 (Survey visit) (approximately 35 days)
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.
Odds Ratio for the Number of Subjects With MCI, Infected With P. Falciparum Parasitemia, for the Niakhar Center in Dakar Area in Senegal
时间窗: At Epoch 1 (Survey visit) (approximately 35 days)
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.
次要结局
- Number of Subjects With Other Medical History Characteristics, Overall(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(At Epoch 1 (Survey visit) (approximately 35 days))
- Number of Subjects With Different P. Falciparum Parasite Densities, by House Information and Center(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 Gender, 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 With Plasmodium Species Other Than P. Falciparum, by JTEG Age Group and Per Total Centers(At Epoch 1 (Survey visit) (approximately 35 days))
- Days With Fever, Overall(At Epoch 1 (Survey visit) (approximately 35 days))
- Number of Subjects With P. Falciparum by Situation Area, Overall(At Epoch 1 (Survey visit) (approximately 35 days))
- Number of Subjects With Different P. Falciparum Densities by Situation Area and Center(At Epoch 1 (Survey visit) (approximately 35 days))
- Number of Subjects With Anti-malarial Therapy, Overall(At Epoch 1 (Survey visit) (approximately 35 days))
- Number of Days With Therapy, Overall(At Epoch 1 (Survey visit) (approximately 35 days))
- Days of Malaria Treatment, Overall(At Epoch 1 (Survey visit) (approximately 35 days))
- Number of Subjects With Fever, Overall(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(At Epoch 1 (Survey visit) (approximately 35 days))
- Number of Subjects With Different P. Falciparum Parasite Densities, Living in the Same House, by Center(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(At Epoch 1 (Survey visit) (approximately 35 days))
- Number of Subjects With P. Falciparum by House Construction Material and Other House Information, Overall(At Epoch 1 (Survey visit) (approximately 35 days))