Tuberculosis, Multidrug-Resistant Clinical Trial
Official title:
Operational Assessment of Laboratory Information System for MDR-TB in Lima, Peru
The objective of this study is to compare the effects of a web-based laboratory information
system (e-Chasqui) between a network of health establishments with access to e-Chasqui
(intervention group) and a network of health establishments without access to e-Chasqui
(control group).
The specific aims are:
1. To compare the "laboratory turn-around-time" (from the date a culture or drug
susceptibility test (DST) result is obtained to the date the result is obtained at the
health center) of samples pertaining to health establishments in the intervention versus
the control group.
2. To compare the "clinical turn-around-time" (from the date the DST result is obtained to
the date the patient is evaluated by a physician in possession of that result) among
multi-drug-resistant tuberculosis (MDR-TB) patients pertaining to health establishments
in the intervention versus control group.
3. To compare the laboratory reporting errors (defined as incorrect smear, culture, or DST
results) between health establishments in the intervention versus control group.
4. To qualitatively assess the acceptability and usability of e-Chasqui among users in
health establishments with access to the system.
The investigators aim to test the following hypotheses:
1. The laboratory turn-around-time for health establishments with e-Chasqui access will be
smaller than that for establishments without e-Chasqui access.
2. The clinical turn-around-time for patients pertaining to health establishments with
e-Chasqui access will be smaller than that for patients in establishments without
e-Chasqui access.
3. Health establishments with e-Chasqui access will have fewer errors compared to those
without e-Chasqui access.
4. Factors associated with acceptability and usability of e-Chasqui by systems users can be
identified.
Delays in starting patients with multi-drug resistant tuberculosis (MDR-TB) on appropriate
medication treatment lead to worsened patient outcomes and increased risk of transmission. In
Peru, the National Tuberculosis Program (NTP) has provided treatment for patients with MDR-TB
since 1996, with cure rates ranging from 48% to 83%. Nonetheless, significant delays exist in
the diagnosis of MDR cases and timely treatment initiation, in particular since MDR-TB
treatment has been scaled to a national level. Our preliminary work has found that the
average turn-around-time (TAT) from the request of a DST to the prescription of appropriate
treatment was 148 days (4.9 months).
An information system could be used to virtually eliminate part of this delay: the time to
communicate results between the different institutions. In 2001 we developed and deployed a
web based medical record system, the PIH-EMR, to assist in the clinical management of these
MDR-TB patients. This system includes a substantial set of data entry and analysis tools for
laboratory results including sputum smears, cultures and DSTs. Over the last six months the
PIH-EMR has been modified to support the decentralization of DSTs in the regional
laboratories. This laboratory component of the PIH-EMR, termed "e-Chasqui," permits web-based
entry of culture and DST results at all regional and central laboratories performing these
tests. In addition, the system includes applications to assess quality control, generate
aggregate reports, notify health centers of new results or contaminated samples, and track
enrolled patients and the status of pending laboratory tests.
The NTP and the National Reference Laboratory (NRL) have agreed to integrate e-Chasqui into
the current management of patients at risk of MDR-TB in two regions, and if effective, to
provide a national network of all laboratories performing DST. Because of the intensive
initial demands on resources and training, the implementation of the information system will
occur in stages (parts A and B of this study).
Broadly put, this study will provide data on whether the use of information systems can be
shown to improve quality of patient care. More specifically, it will assess the impact of
e-Chasqui on reducing reporting delays and laboratory data errors, and improving patient
outcomes.
This is a prospective observational controlled study to compare the effects of a web-based
laboratory information system (e-Chasqui) between a network of health establishments with
e-Chasqui access (intervention group) compared with a network of health establishments
without e-Chasqui access (control group). The data is being collected by the overarching
study "Operational Assessment of Diagnostic Methods for MDR-TB in Lima, Peru."
The study is planned in two parts: Part A will be a simultaneous control study occurring in
the "transition" period comparing endpoints in those health establishments with e-Chasqui
access to those in matched health establishments without e-Chasqui access. Part B will be an
historical control study comparing endpoints in the establishments which gain initial
e-Chasqui access, before (historical control) and after (intervention) the implementation.
Data sources include: patient charts, interview with health providers to confirm or clarify
accuracy of data in patient charts, microbiology registries at local, regional and national
laboratories, and the information system database. The total number of subjects to be
enrolled study-wide is 1849.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT05871489 -
Strengthening Evidence on Optimal Multidrug-resistant Tuberculosis Treatment Regimens
|
||
Active, not recruiting |
NCT02715271 -
Study of TB Lesions Obtained in Therapeutical Surgery
|
||
Active, not recruiting |
NCT04179500 -
A Trial to Evaluate the Male Reproductive Safety of Pretomanid in Adult Male Participants With Drug Resistant Pulmonary Tuberculosis Volunteers
|
Phase 2 | |
Completed |
NCT03086486 -
Various Doses and Durations of Linezolid Plus Bedaquiline & Pretomanid in Participants With Drug Resistant Tuberculosis
|
Phase 3 | |
Not yet recruiting |
NCT06441006 -
Program for Rifampicin-Resistant Disease With Stratified Medicine for Tuberculosis
|
Phase 3 | |
Completed |
NCT03303963 -
DIAgnostics for Multidrug Resistant Tuberculosis in Africa
|
||
Completed |
NCT02413931 -
Nosocomial Transmission of MDR-TB in Bucharest, Romania
|
||
Recruiting |
NCT05306223 -
A Study of an Oral Short-course Regimen Including Bedaquiline for the Treatment of Participants With Multidrug-resistant Tuberculosis in China
|
Phase 4 | |
Completed |
NCT02573350 -
A Trial to Evaluate Safety, Tolerability, and Efficacy of Orally Administered OPC-67683
|
Phase 2 | |
Completed |
NCT02597621 -
Biomarkers for Therapy Response in Drug-resistant Tuberculosis
|
||
Recruiting |
NCT05555303 -
Preventing Acquired Resistance: Strengthen TB Treatment by Adding Amikacin in the First Treatment Week of Multidrug-resistant Tuberculosis
|
Phase 2 | |
Recruiting |
NCT03828201 -
Efficacy and Tolerability of Bedaquiline, Delamanid, Levofloxacin, Linezolid, and Clofazimine to Treat MDR-TB
|
Phase 2 | |
Recruiting |
NCT01212003 -
Training Protocol on the Natural History of Tuberculosis
|
||
Terminated |
NCT03237182 -
The Individualized M(X) Drug-resistant TB Treatment Strategy Study
|
Phase 4 | |
Completed |
NCT03338621 -
Trial to Evaluate the Efficacy, Safety and Tolerability of BPaMZ in Drug-Sensitive (DS-TB) Adult Patients and Drug-Resistant (DR-TB) Adult Patients
|
Phase 2/Phase 3 | |
Not yet recruiting |
NCT05007795 -
Test to Treat TB: Impact of Sputum Sequencing-guided Individualised Therapy on Outcomes in Drug-resistant Tuberculosis
|
N/A | |
Completed |
NCT03728725 -
Xpert MTB/XDR Clinical Evaluation Trial
|
||
Completed |
NCT02589782 -
Pragmatic Clinical Trial for a More Effective Concise and Less Toxic MDR-TB Treatment Regimen(s)
|
Phase 2/Phase 3 | |
Recruiting |
NCT02619994 -
Treatment Shortening of MDR-TB Using Existing and New Drugs
|
Phase 2 | |
Completed |
NCT01918397 -
Efficacy and Safety of Levofloxacin for the Treatment of MDR-TB
|
Phase 2 |