Changes to trial information |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Reporting |
Plan to share IPD |
15/04/2019 |
upon request of the board |
Undecided |
Yes |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Reporting |
IPD description |
15/04/2019 |
the plan was already existing, the coordination team was not sure about the mandatory requirement for that |
|
Each participant included into the study receives a unique identifier, babies will receive a different identifier that is connected to the one of their mothers. The format of the Study ID will be the following:
- F18-X0001-XX
o F18 = study abbreviation
o X = 1 for mothers, 2 for children, 3 for twin
o 0001 – 5200 = sequential enrolled participants
o X = T for Antananarivo (Tana), F for Fianarantsoa
o X = A to U for the different sites
The identity of the participant is kept on site Data is recorded on paper-based case report forms (CRF) and then digitalized using the REDCap software system.
Demographic, anthropometric and clinical data will be transcribed directly into the CRF. Haemoglobin (Hb) will be measured using the “HemoCue” system, which consists of a handheld device to measure Hb in a drop of blood soaked into a strip. Hb measurement results will be registered in the CRF. Rapid test results without a reader (as in the HemoCue) system such as the POC-CCA are judged by a trained study nurse and the result written into the CRF.
|
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Reporting |
IPD-Sharing time frame |
15/04/2019 |
the plan was already existing, the coordination team was not sure about the mandatory requirement for that |
|
Both the hard version (paper CRF) and electronic version of the study data is archived. Study documents and participants folder are archived at University of Antananarivo, University of Fianarantsoa and CICM according to the institutional SOPs for at least 10 years. They are kept in a temperature and humidity controlled environment with protection against theft and pests. Electronic archiving of study data is based on a study specific standard operating procedure. |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Reporting |
Key access criteria |
15/04/2019 |
the plan was already existing, the coordination team was not sure about the mandatory requirement for that |
|
Access to the REDCap database of freeBILy-MAD study will be granted to freeBILy-MAD study team for quality control purposes. Data may be shared with other sites at the request of the freeBILy steering committee. Data can be shared with partner institutions after request to and confirmation of the PI. For external requests, the Scientific Review Committee and the PI decide, based on information such as the study protocol.
REDCap allows the export into several commonly used data formats, including csv.
|
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Reporting |
Study protocol document |
15/04/2019 |
the plan was already existing, the coordination team was not sure about the mandatory requirement for that |
|
Study Protocol, Statistical Analysis Plan, Informed Consent Form |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Intervention |
Intervention List |
16/04/2019 |
In response to reviewer request |
|
Control Group, Praziquantel, 40mg/kg following diagnosis , One dose , Pregnant women and newborns are not diagnosed via the use of a rapid diagnostic test so they will be treated with praziquantel according to the national guidelines which currently don't include treatment for children under 5 years and it includes the treatment for pregnant women just in case of a certain diagnosis. The diagnosis cannot be done at the PHCC so the treatment, if given, will not be performed on the same day of the consultation., 2600, Uncontrolled |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Reporting |
IPD description |
25/04/2019 |
Reviewers request |
Each participant included into the study receives a unique identifier, babies will receive a different identifier that is connected to the one of their mothers. The format of the Study ID will be the following:
- F18-X0001-XX
o F18 = study abbreviation
o X = 1 for mothers, 2 for children, 3 for twin
o 0001 – 5200 = sequential enrolled participants
o X = T for Antananarivo (Tana), F for Fianarantsoa
o X = A to U for the different sites
The identity of the participant is kept on site Data is recorded on paper-based case report forms (CRF) and then digitalized using the REDCap software system.
Demographic, anthropometric and clinical data will be transcribed directly into the CRF. Haemoglobin (Hb) will be measured using the “HemoCue” system, which consists of a handheld device to measure Hb in a drop of blood soaked into a strip. Hb measurement results will be registered in the CRF. Rapid test results without a reader (as in the HemoCue) system such as the POC-CCA are judged by a trained study nurse and the result written into the CRF.
|
Will individual participant data be available (including data dictionaries)? --> yes
What data in particular will be shared? --> all of the individual participant data collected during the trial, after anonymization
Each participant included into the study receives a unique identifier, babies will receive a different identifier that is connected to the one of their mothers. The format of the Study ID will be the following:
- F18-X0001-XX
o F18 = study abbreviation
o X = 1 for mothers, 2 for children, 3 for twin
o 0001 – 5200 = sequential enrolled participants
o X = T for Antananarivo (Tana), F for Fianarantsoa
o X = A to U for the different sites
The identity of the participant is kept on site Data is recorded on paper-based case report forms (CRF) and then digitalized using the REDCap software system.
Demographic, anthropometric and clinical data will be transcribed directly into the CRF. Haemoglobin (Hb) will be measured using the “HemoCue” system, which consists of a handheld device to measure Hb in a drop of blood soaked into a strip. Hb measurement results will be registered in the CRF. Rapid test results without a reader (as in the HemoCue) system such as the POC-CCA are judged by a trained study nurse and the result written into the CRF.
|
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Reporting |
IPD-Sharing time frame |
25/04/2019 |
Reviewers request |
Both the hard version (paper CRF) and electronic version of the study data is archived. Study documents and participants folder are archived at University of Antananarivo, University of Fianarantsoa and CICM according to the institutional SOPs for at least 10 years. They are kept in a temperature and humidity controlled environment with protection against theft and pests. Electronic archiving of study data is based on a study specific standard operating procedure. |
When will data be available (start and end dates)? --> Immediately following the publication and no end date is cosnidered for sharing.
Both the hard version (paper CRF) and electronic version of the study data is archived. Study documents and participants folder are archived at University of Antananarivo, University of Fianarantsoa and CICM according to the institutional SOPs for at least 10 years. They are kept in a temperature and humidity controlled environment with protection against theft and pests. Electronic archiving of study data is based on a study specific standard operating procedure. |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Reporting |
Key access criteria |
25/04/2019 |
Reviewers request |
Access to the REDCap database of freeBILy-MAD study will be granted to freeBILy-MAD study team for quality control purposes. Data may be shared with other sites at the request of the freeBILy steering committee. Data can be shared with partner institutions after request to and confirmation of the PI. For external requests, the Scientific Review Committee and the PI decide, based on information such as the study protocol.
REDCap allows the export into several commonly used data formats, including csv.
|
With whom? --> Data can be shared with partner institutions after request to and confirmation of the PI. For external requests, the Scientific Review Committee and the PI decide, based on information such as the study protocol.
For what type of analyses? --> any purposes covered by the informed consent
By what mechanism will data be made available? --> data are stored at BNITM in the protected owncloud server. To gain access to the data request should go via email to the sponsor and the data manager. Contact email will be provided at the end of the study
Access to the REDCap database of freeBILy-MAD study will be granted to freeBILy-MAD study team for quality control purposes. Data may be shared with other sites at the request of the freeBILy steering committee. Data can be shared with partner institutions after request to and confirmation of the PI. For external requests, the Scientific Review Committee and the PI decide, based on information such as the study protocol.
REDCap allows the export into several commonly used data formats, including csv.
|
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Eligibility |
Age group |
15/05/2019 |
Correction to include all ages specified |
Infant: 0 Month-23 Month, Adolescent: 13 Year-18 Year, Adult: 19 Year-44 Year, Middle Aged: 45 Year(s)-64 Year(s) |
Infant: 0 Month-23 Month, Preschool Child: 2 Year-5 Year, Child: 6 Year-12 Year, Adolescent: 13 Year-18 Year, Adult: 19 Year-44 Year, Middle Aged: 45 Year(s)-64 Year(s) |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Trial Information |
Recruitment status |
07/02/2020 |
Recruitment completed on the 5th of February 2020. 5203 women are part of the study |
Recruiting |
Closed to recruitment,follow-up continuing |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Trial Information |
Final no of participants |
27/02/2023 |
The total of 5200 could not be reached |
|
5114 |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Trial Information |
Recruitment status |
27/02/2023 |
The trial follow-up has been finalised |
Closed to recruitment,follow-up continuing |
Completed |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Contact People |
Contacs List |
27/02/2023 |
Left the BNITM |
Principal Investigator, Norbert , Schwarz, Prof., schwarznorbert@bni-hamburg.de, , +494042818503, Bernhard Nocht Strasse 74, Hamburg, 20359, Germany, Group leader BNITM |
Scientific Enquiries, Norbert , Schwarz, Prof., schwarznorbert@bni-hamburg.de, , +494042818503, Bernhard Nocht Strasse 74, Hamburg, 20359, Germany, Freelance scientst |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Contact People |
Contacs List |
27/02/2023 |
Prof Norbert Schwarz took over the role of scientific enquiries |
Scientific Enquiries, Daniela, Fusco, Dr., fusco@bnitm.de, , +494042818503, Bernhard Nocht Strasse 74, Hamburg, , Germany, Post doc BNITM |
Public Enquiries, Daniela, Fusco, Dr., fusco@bnitm.de, , +494042818503, Bernhard Nocht Strasse 74, Hamburg, , Germany, Post doc BNITM |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Contact People |
Contacs List |
27/02/2023 |
Dr Fusco took over the role of PI, after communication and approval by ethical commissions and donors, after Prof Schwarz left the institute |
Public Enquiries, Daniela , Fusco, Dr., fusco@bnitm.de, , +494042818243, Bernhard Nocht Strasse, 74, Hamburg, , Germany, Senior postdoc BNITM |
Principal Investigator, Daniela , Fusco, Dr., fusco@bnitm.de, , +494042818243, Bernhard Nocht Strasse, 74, Hamburg, , Germany, Group leader BNITM |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Contact People |
Contacs List |
27/02/2023 |
Changed role at the institute |
Public Enquiries, Daniela, Fusco, Dr., fusco@bnitm.de, , +494042818503, Bernhard Nocht Strasse 74, Hamburg, , Germany, Post doc BNITM |
Public Enquiries, Daniela, Fusco, Dr., fusco@bnitm.de, , +494042818503, Bernhard Nocht Strasse 74, Hamburg, , Germany, Group leader BNITM |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Trial Information |
Completion date |
27/02/2023 |
Due to delayed start |
04 Sep 2021 |
01 Sep 2022 |