Changes to trial information |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Collaborators |
Collaborators List |
09/04/2019 |
Scientific Coordinator of EMPIRICAL Project |
|
Cinta Moraleda, Avenida de Cordoba , Madrid, 28041, Spain |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Collaborators |
Collaborators List |
09/04/2019 |
Data Scientist |
|
Sara Dominguez, Avenida de Cordoba , Madrid, 28041, Spain |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Collaborators |
Collaborators List |
09/04/2019 |
Safety Coordinator |
|
Luis Prieto, Avenida de Cordoba, Madrid, 28041, Spain |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Collaborators |
Collaborators List |
09/04/2019 |
TB Speed Coordinator |
|
Olivier Marcy, Bourdeaux University, Bourdeaux, , France |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Collaborators |
Collaborators List |
09/04/2019 |
Pharmacoeconomics |
|
Valeriane Leroy, INSERM, Bourdeaux, , France |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Collaborators |
Collaborators List |
09/04/2019 |
Ethics Coordination |
|
Laura Mangiarini, PENTA Foundation, Padova, , Italy |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Collaborators |
Collaborators List |
09/04/2019 |
Ethics Coordination |
|
Alessandra Nardone, PENTA Foundation, Padova, , Italy |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Collaborators |
Collaborators List |
09/04/2019 |
PI Cote D'Ivoire |
|
Raoul Moh, Programme PACCI, Abidjan, , Cote Divoire |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Collaborators |
Collaborators List |
09/04/2019 |
PI Malawi |
|
Pui Ying Iroh Tam, Malawi Wellcome Trust, Blantyre, , Malawi |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Collaborators |
Collaborators List |
09/04/2019 |
PI Maputo |
|
Christopher Buck, Hospital Central Maputo, Maputo, , Mozambique |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Collaborators |
Collaborators List |
09/04/2019 |
PI Manhica |
|
Nelson, Tembe, Manhica, , Mozambique |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Collaborators |
Collaborators List |
09/04/2019 |
PI Uganda |
|
Victor Musiime, Makerere University, Kampala, , Uganda |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Collaborators |
Collaborators List |
09/04/2019 |
PI Zambia |
|
Chishala Chabala, Lusaka Teaching Hospital, Lusaka, , Zambia |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Collaborators |
Collaborators List |
09/04/2019 |
PI Zimbabwe |
|
Hilda Mujuru , University of Zimbabwe, Harare, , Zimbabwe |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Collaborators |
Collaborators List |
09/04/2019 |
Laboratory Responsible |
|
Matthew Bates, University of Lincoln, Lincoln, , United Kingdom |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Collaborators |
Collaborators List |
09/04/2019 |
correction
|
Cinta Moraleda, Avenida de Cordoba , Madrid, 28041, Spain |
Cinta Moraleda, Fundacion 12 Octubre, Madrid, 28041, Spain |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Collaborators |
Collaborators List |
09/04/2019 |
correction |
Sara Dominguez, Avenida de Cordoba , Madrid, 28041, Spain |
Sara Dominguez, Fundacion 12 Octubre, Madrid, 28041, Spain |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Collaborators |
Collaborators List |
09/04/2019 |
correction |
Luis Prieto, Avenida de Cordoba, Madrid, 28041, Spain |
Luis Prieto, Fundacion 12 Octubre, Madrid, 28041, Spain |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Reporting |
IPD-Sharing time frame |
09/04/2019 |
as required by WHO |
1 year after completion of the study. |
Within 12 months of the completion of the study. |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Reporting |
IPD URL |
09/04/2019 |
The website will be available soon |
|
www.empirical.org |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Trial Information |
Public title |
09/04/2019 |
edit |
EMPIRICAL |
Empirical treatment against cytomegalovirus and tuberculosis in HIV-infected infants with severe pneumonia: a multicenter, open-label randomized controlled clinical trial |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Collaborators |
Collaborators List |
10/04/2019 |
forgot |
|
David Burger, Stichting Katholieke Universiteit Radboudumc , Nimega, , Netherlands |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Collaborators |
Collaborators List |
10/04/2019 |
mistake |
Nelson, Tembe, Manhica, , Mozambique |
Nelson Tembe, CISM, Manhica, , Mozambique |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Reporting |
IPD URL |
10/04/2019 |
mistake |
www.empirical.org |
www.empiricalEDCTP.eu |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Trial Information |
Anticipated trial start date |
18/02/2022 |
Delay in approvals |
01 Jan 2020 |
01 Feb 2020 |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Trial Information |
Actual trial start date |
18/02/2022 |
Delay in approvals |
|
01 Feb 2020 |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Trial Information |
Anticipated date of last follow up |
18/02/2022 |
Covid-19 pandemics. A no-cost extension has been granted by EDCTP |
01 Jan 2023 |
31 Jan 2025 |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Trial Information |
Recruitment status |
18/02/2022 |
enrolment ongoing |
Not yet recruiting |
Recruiting |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Collaborators |
Collaborators List |
19/02/2022 |
No longer working in the project |
Luis Prieto, Fundacion 12 Octubre, Madrid, 28041, Spain |
|
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Collaborators |
Collaborators List |
19/02/2022 |
New collaborator |
|
Tisungan Mvalo, Kamuzu Central Hospital, Lilongwe, , Malawi |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Collaborators |
Collaborators List |
19/02/2022 |
typo |
Tisungan Mvalo, Kamuzu Central Hospital, Lilongwe, , Malawi |
Tisungane Mvalo, Kamuzu Central Hospital, Lilongwe, , Malawi |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Collaborators |
Collaborators List |
19/02/2022 |
New collaborator |
Tisungan Mvalo, Kamuzu Central Hospital, Lilongwe, , Malawi |
Tisungane Mvalo, Kamuzu Central Hospital, Lilongwe, , Malawi |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Collaborators |
Collaborators List |
19/02/2022 |
new collaborator |
Tisungan Mvalo, Kamuzu Central Hospital, Lilongwe, , Malawi |
Lola Madrid, Fundacion 12 de Octubre, Madrid, , Spain |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Collaborators |
Collaborators List |
19/02/2022 |
new collaborator |
|
Tisungane Mvalo, Kamuzu Central Hospital, Lilongwe, , Malawi |