Dried Blood Spot Test to Assess TB in Pregnancy in Remote and Resource Limited Areas
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,424
- 试验地点
- 12
- 主要终点
- diagnostic feature of test 3 G q-PCR capillary blood compared to gold stantard test
研究概览
简要总结
Despite being a key contributor to maternal mortality in high-burden regions, TB in pregnancy is a hugely neglected area of global public health. During pregnancy, the symptoms of TB are often overlooked and undiagnosed because they are vague, non-specific, and can be very similar to common complaints during pregnancy. Women with TB in pregnancy are at an increased risk of anemia and perinatal death.
The DROP-TB project aims to expand the tuberculosis (TB) detection testing in pregnancy by creating a system where blood samples are collected from women at their local healthcare clinics instead of/or at national-level TB diagnostic centres where visits can require substantial travel and cost. Blood samples collected in specific RNA stabilizing tubes and on specific storing paper filters are collected from pregnant women with presumptive TB and transported to a central TB testing facility and analyzed by real-time polymerase chain reaction (qPCR).
The DROP-TB method measures the mRNA expressions known to be markers of TB infection and disease. Based on veinous blood sampling, those signatures have showed high sensitivity (93%) and specificity (97%), can differentiate between active and latent infection, and performs well in the presence of other infections such as HIV. The DROP-TB program was specifically designed to increase the coverage of TB testing in pregnancy to improve health outcomes for women and their unborn children.
The evidence generated from this program will demonstrate the feasibility of this program in providing TB diagnosis to women in rural and remote regions of LMIC with the example of Madagascar. Evidence will be presented to policy makers as a case to support the national scale up of the program in LMICs.
详细描述
With this Grand Challenges Canada Transition to scale DROP-TB program, the Institut Pasteur de Madagascar will:
- Conduct a validation trial of the DROP-TB screening program in rural Madagascar, enrolling 3,500 women with presumptive TB, of which ~1,229 will be pregnant women
- Support the development of laboratory capacity to collect veinous, DBS and other samples for qPCR at the 101 TB testing centres participating in the trial and implement standard operating procedures for DROP-TB testing
- Assess the implementation and cost of the shipping program to bring different type of blood samples from community-based centres to national health centres for testing.
This is a cross -sectional study conducted on pregnant women suspected of having pulmonary TB (n = 1300), pregnant women without apparent pathology (controlled pregnant women), TB indemnity and without notion of tuberculous contact ( n = 50) and non -pregnant women were also free of TB and without a notion of tuberculous contact to control for tests (n = 50).
The sample size was calculated in the hypothesis of a conservative situation by comparing confirmed tuberculous participants (positive gold standard diagnostic test) and non -tuberculous (negative gold standard diagnostic test). The blood signature measured on venous blood samples showed a sensitivity of 93% in pregnant women. If the acceptable sensitivity for the new testing method is estimated at 96% and the prevalence of pulmonary TB in pregnant women in peripheral health centers is 12% and a precision of ± 7 is desired %and an α risk of 5%, a potency of 80%, the required sample size is 1167 pregnant women of which 140 are bacteriologically confirmed as active TB and 1027 controls. Considering an enrollment or rejection rate of 20%, the total needed sample would be 1,400 pregnant women in the CDT functions in the regions of Madagascar.
- Data collection:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Group cases:
- •pregnant women aged over 15 adressed to TB diagnostic and treatment centers for a bacteriological diagnosis of pulmonary TB
- •Or with one or more symptoms of presumptive TB: cough, fatigue, weight loss, fever, chills, night sweats, shortness of breath, loss of appetite
- •agreed to participate in the study with full knowledge of the facts and signed an informed consent
- •Group control:
- •pregnant women over 15 years referred to a prenatal health center,
- •without known or clinically observed pathology associated with pregnancy
- •agreed to participate in the study with full knowledge of the facts and signed an informed consent
排除标准
- •Group cases :
- •Patients undergoing TB treatment for more than 2 weeks
- •Treatments with immunosuppressive drugs (≥ 14 consecutive days);
- •Progressive disease which does not allow venous blood sampling and venous capillary sampling;
- •All other clinical manifestations deemed incompatible for the study
- •Group Control :
- •No clinical signs of TB, no history of previous TB
- •No other known or clinically observed pathologies
结局指标
主要结局
diagnostic feature of test 3 G q-PCR capillary blood compared to gold stantard test
时间窗: at inclusion
The diagnostic performance are estimated by the sensitivity and specificity of the 3G q-PCR test with capillary blood compared to the sputum test as gold standard
diagnostic feature of test 3 G q-PCR capillary blood compared to 3 G q-PCR veinous blood
时间窗: at inclusion
The diagnostic performance are estimated by the sensitivity and specificity of the 3G q-PCR test with capillary blood compared to the 3 G q-PCR veinous blood as a reference test
次要结局
未报告次要终点