An observational study in Tuberculosis, sponsored by Institut Pasteur de Madagascar. Completed at 12 sites in Madagascar. Open to female participants aged 15 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-28.
Sponsored by Institut Pasteur de Madagascar · Observational
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.
With this Grand Challenges Canada Transition to scale DROP-TB program, the Institut Pasteur de Madagascar will:
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:
Clinical data as well as biological samples (blood and sputum samples) are collected at the inclusion, the samples are analyzed at the Pasteur Institute of Madagascar.
The data collection is done on paper based questionnaire where the data of each patient is recorded. The results of biological tests, paraclinical investigations as well as their results are also be recorded for each participant with the help of this questionnaire.
Data entry:
The data are collected and transferred to a single database (REDCap). The REDCap system is compliant with the FDA standard CRF-21 part 11 as a reliable tool that allows to improve data quality and guarantee traceability. The data is stored on an IPM's secure server.
Data management and quality control:
Data management is carried out by the IPM's Epidemiology and Clinical Research Unit (EPI-RC) data management team which closely collaborate with the study coordinators.
Access to this database is restricted and secure. The list of persons with access rights appears in the data management manual. The data manager of the study is responsible for the security and quality of the data. A list of errors and inconsistencies detected in the database are regularly sent to the field team to make corrections. This regular monitoring will allow to improve the quality of the database. The request for partial or total extraction of the database must be the subject of a manuscript request and must have the consent of the epidemiological coordinator and scientific managers of the project.
Statistical analyzes:
The entire study data is grouped into a single database and cleaned prior to any statistical processing of the data. All statistical analyzes will be performed on the GraphPad PRism and R software (http://www.R-project.org/) by designated competent persons for each data category studied.
Management of Potential Unnecessary Events:
All undesirable events, observed during the study will be recorded in an observation register, which is either their severity and the link with the study procedures.
Events will be coded using the 10th International Classification of Diseases (CIM-10) http://apps.who.int/classifications/icd10/browse).
Project investigators ensure the internal monitoring of the project at the study sites and are directly responsible for the collection, storage and transportation of the samples. Experienced laboratory technologists are in charge of manipulating and preparing samples for qPCR and DBS techniques at IPM.
Investigators and coordinators ensure that:
The Coordinator and supervisors, recruited by the IPM, plan to visit the study sites regularly and is authorized to inspect the study documents so that patient confidentiality is maintained, in accordance with local regulations. The investigator cooperates with the coordinator so that any problems are identified during these control visits or resolved.
IPM has specific quality controls and assurance procedures developed and maintained in its laboratories and research units.
1,170 studies on the registry are indexed under Tuberculosis; 175 are open to participants now.
This study's enrollment of 1,424 is above the median of 253 across 317 observational studies indexed under Tuberculosis.
Browse Tuberculosis studies →Institut Pasteur de Madagascar is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
All pregnant women addressed to 101 TB diagnostic and treatment centers of Madagascar
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Group cases:
Group control:
Exclusion Criteria:
Group cases :
Group Control :
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This group enrolled as cases
Diagnostic Test: 3G DBS · Diagnostic Test: Sputum Test · Diagnostic Test: 3G Veinous Blood
This group enrolled as controls
Diagnostic Test: 3G DBS · Diagnostic Test: 3G Veinous Blood
Collection of capillary blood samples for the 3G q-PCR test
Also known as: 3G qPCR test with Dried Blot Spot Samples
Collection of sputum for test culture, microscopy, GeneXpert
Also known as: Culture sputum, GeneXpert Sputum, Microscopy Sputum
Collection liquid veinous blood for the 3G q-PCR test
diagnostic feature of test 3 G q-PCR capillary blood compared to gold stantard test
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
Time frame: at inclusion
diagnostic feature of test 3 G q-PCR capillary blood compared to 3 G q-PCR veinous blood
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
Time frame: at inclusion
Plan to share: Undecided — At the time of submission to the ethics committee, it will be decided to make a plan a share IPD
This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Institut Pasteur de Madagascar