Changes to trial information |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Trial Information |
Target no of participants |
14/05/2014 |
changed data |
|
169 |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Trial Information |
Target no of participants |
14/05/2014 |
Predicted sample size |
169 |
400 |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Study Design |
Intervention assignment |
13/05/2014 |
Since the effect of the AFYA-biscuits is unknown, it was decided to randomize to either biscuits or nothing. |
Parallel: different groups receive different interventions at same time during study |
Single group: all participants receive same intervention throughout study |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Study Design |
Allocation sequence |
13/05/2014 |
Further clarified. |
Simple randomisation using a radomisation table created by a computer software program |
Simple randomisation using a radomisation table created by a computer software program. Patients select a closed enveloped with a number, which then is found on the randomisation table. |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Ethics |
IsApprovedByEC |
13/05/2014 |
changed due to the new, approved protocol in which this trial is incorporated. |
true |
true |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Trial Information |
Trial type |
13/04/2010 |
Modified |
|
CCT |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Trial Information |
Recruitment status |
19/07/2010 |
Modified |
Not yet recruiting |
Temporary halt or suspension |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Trial Information |
Target no of participants |
14/05/2014 |
changed information |
|
400 |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Sponsors |
Sponsors List |
13/05/2014 |
Has been the original primary sponsor, but was not added due to a mistake earlier. |
Primary Sponsor |
Primary Sponsor |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Trial Information |
Target no of participants |
14/05/2014 |
changed data |
|
|
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Trial Information |
Target no of participants |
14/05/2014 |
changed data |
169 |
|
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Sponsors |
Sponsors List |
13/05/2014 |
Is one of the primary sponsor, lost in the previous revision of the registry. |
Primary Sponsor |
Primary Sponsor |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Trial Information |
Trial type |
19/07/2010 |
Modified |
CCT |
CCT |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Trial Information |
Target no of participants |
14/05/2014 |
Actual sample size not known yet |
169 |
|
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Study Design |
Masking / blinding |
13/04/2010 |
|
|
|
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Trial Information |
Trial description |
13/05/2014 |
The trial was part of a earlier protocol, which was completed in 2013. However, the trial was incorporated in another protocol,with focus on nutritional status among TB suspects and patients and healthy controls. |
We hypothesize that in a limited-resource-setting with , it is possible to reduce mortality in TB and aTBneg (assumed TB negative) patients by focussing on patients needing most attention.
Our objective is to reduce mortality among individuals with symptoms of TB infection using simple tools (TBscore and suPAR)to provide individualized treatment.
If TB mortality can be reduced with simple measures available in high burden settings, this will be a major step forward in the battle against TB. |
It is hypothesised that food supplementation for pulmonary TB will lower mortality although
the evidence hitherto is inconclusive. Thus further, well powered studies are needed to collect
evidence that food supplementation is beneficial for patients suspected of having TB.
We aim to identify the prevalence of malnutrition in pulmonary TB suspects, pulmonary TB patients,
and healthy controls and to evaluate the use of a standardized nutritional support to lower mortality
in PTB suspects. |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Trial Information |
Target no of participants |
13/05/2014 |
changed due to the new, approved protocol in which this trial is incorporated. |
|
400 |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Trial Information |
Recruitment status |
13/04/2010 |
Modified |
Not yet recruiting |
Not yet recruiting |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Trial Information |
Recruitment status |
13/05/2014 |
Modified |
Temporary halt or suspension |
Open to recruitment: actively recruiting participants |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Eligibility |
Inclusion criteria |
13/05/2014 |
3 weeks of cough changed to current cough, since we have previously shown, that 1/3 of all smear positive TB-patients are lost if cough>3 weeks is applied. |
- adults (> 15 years)
- At least one symptom indicating possible TB: 3 weeks of cough, sputum production or weight loss.
- Residents or long-term guests of Bandim I, Bandim II, Belem, Mindara and Cuntum.
|
- adults (> 15 years)
- At least one symptom indicating possible TB: current cough, sputum production or weight loss.
- Residents or long-term guests of Bandim I, Bandim II, Belem, Mindara and Cuntum.
|
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Ethics |
IsApprovedByEC |
13/05/2014 |
New protocol |
true |
true |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Trial Information |
Official scientific title |
13/05/2014 |
The trial has been incorporated into another protocol, where suPAR is not included. |
TBscore and suPAR used to PREDict and INtervene Against high Mortality (PREDINAM) - a randomised trial |
TBscore (and suPAR) used to PREDict and INtervene Against high Mortality (PREDINAM) - a randomised trial |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Trial Information |
Official scientific title |
13/05/2014 |
The trial was part of a earlier protocol, which was completed in 2013. However, the trial was incorporated in another protocol, where suPAR was not included. |
TBscore and suPAR used to PREDict and INtervene Against high Mortality (PREDINAM) - a randomised trial |
TBscore (and suPAR) used to PREDict and INtervene Against high Mortality (PREDINAM) - a randomised trial |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Trial Information |
Trial type |
29/11/2011 |
Modified |
RCT |
RCT |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Study Design |
Masking / blinding |
13/04/2010 |
|
Open-label (masking not used) |
Open-label (masking not used) |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Trial Information |
Trial description |
13/05/2014 |
The trial has been incorporated into another protocol. |
We hypothesize that in a limited-resource-setting with , it is possible to reduce mortality in TB and aTBneg (assumed TB negative) patients by focussing on patients needing most attention.
Our objective is to reduce mortality among individuals with symptoms of TB infection using simple tools (TBscore and suPAR)to provide individualized treatment.
If TB mortality can be reduced with simple measures available in high burden settings, this will be a major step forward in the battle against TB. |
It is hypothesised that food supplementation for pulmonary TB will lower mortality although
the evidence hitherto is inconclusive. Thus further, well powered studies are needed to collect
evidence that food supplementation is beneficial for patients suspected of having TB.
We aim to identify the prevalence of malnutrition in pulmonary TB suspects, pulmonary TB patients,
and healthy controls and to evaluate the use of a standardized nutritional support to lower mortality
in PTB suspects. |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Trial Information |
Actual trial start date |
13/05/2014 |
changed due to the new, approved protocol in which this trial is incorporated. |
|
2014-05-13 |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Eligibility |
Exclusion criteria |
13/05/2014 |
According to the new protocol. |
None
|
The subject may withdraw at will at any time.
The subject may be withdrawn from the trial at the discretion of the Sponsor¿Investigator if judged
noncompliant with trial procedures.
There are no known side effects to AFYA¿. However, should a participant develop allergic
symptoms (rash, trouble of breathing or flushing) he/she is advised to contact the responsible field
assistant. All participating patients are informed about allergic symptoms and are supplied with a
contact telephone number.
In addition, a subject must be withdrawn if the following applies:
¿ Moving outside of study area to a place unreachable for follow¿up. The observation time until
moving will be used. |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Trial Information |
Trial type |
19/07/2010 |
Modified |
CCT |
RCT |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Trial Information |
Anticipated date of last follow up |
13/05/2014 |
changed due to the new, approved protocol in which this trial is incorporated. |
|
2015-06-12 |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Trial Information |
Trial phase |
09/07/2018 |
pactr update |
|
Not Applicable |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Trial Information |
Disease(s) |
09/07/2018 |
pactr update |
|
Nutritional, Metabolic, Endocrine |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Trial Information |
Completion date |
09/07/2018 |
update |
|
15 Jun 2015 |