Prevalence of drug-resistant tuberculosis in Sinaloa Mexico
| ISRCTN | ISRCTN18957388 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18957388 |
- Submission date
- 21/07/2022
- Registration date
- 10/08/2022
- Last edited
- 25/04/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
Background and study aims
Tuberculosis (TB) is a disease caused by Mycobacterium tuberculosis that has resulted in millions of deaths worldwide, especially in developing countries. Among the most important risk factors for the development of TB is infection with the human immunodeficiency virus (HIV) and type 2 diabetes mellitus (T2DM). However, the appearance of drug-resistant M tuberculosis (DR-MTB) strains has significantly complicated the prevention, control, and treatment actions of TB, becoming a threat to public health. In this regard, Sinaloa is a Northwest state in México, which has been identified as an endemic area for TB disease; notwithstanding, the prevalence is unknown, as well as the prevalence of DR-MTB in the HIV and T2DM populations. The objective of this study is to evaluate the prevalence of DR-MTB in patients with HIV or T2DM in Sinaloa, from the analysis of a database of the National Epidemiological Surveillance System (SINAVE) during the period 2019-2022.
Who can participate?
Patients aged between 18 and 85 years old with a positive diagnosis for pulmonary M tuberculosis in populations with HIV or T2DM, in which diagnosis was confirmed by the GeneXpert technique
What does the study involve?
This is not an interventional study and no clinical manipulation of patients is required. This cross-sectional and retrospective study will be involved the calculation of the prevalence of TB in HIV and T2DM groups, as well as the DR-MTB for rifampicin in both groups. Also, clinical, and demographic variables will be studied from the data recorded in the database of SINAVE.
What are the possible benefits and risks of participating?
Benefits for the health service system in an endemic state will be obtained to identify risk factors and best-clinical management in HIV and T2DM populations diagnosed with TB. There are no risks related to patients.
Where is the study run from?
This study is a collaboration of the Health Services of Sinaloa, the State Public Health Laboratory of Sinaloa Autonomous University of Sinaloa, Faculty of Biological Chemistry Sciences (Mexico)
When is the study starting and how long is it expected to run for?
January 2022 to January 2023
Who is funding the study?
National Council for Science and Technology Mexico (Consejo Nacional de Ciencia y Tecnología México) (Mexico)
Who is the main contact?
Prof Geovanna Nallely Quiñonez Bastidas
geovanna.quinonez@uas.edu.mx (Mexico)
Contact information
Principal Investigator
Calz de las Americas Nte 2771
Cd Universitaria
Burocrata
Cualican
80030
Mexico
 ORCID ID |
0000-0002-8006-3022 |
|---|---|
| Phone | +(52) 5521783696 |
| geovanna.quinonez@uas.edu.mx |
Scientific
Calz de las Americas Nte 2771
Ciudad Universitaria
Burocrata
Culiacán
80030
Mexico
| ORCID ID |
0000-0002-7824-6639 |
|---|---|
| Phone | +52 6671337826 |
| ulises.osuna@uas.edu.mx |
Study information
| Study design | Observational cross-sectional retrospective study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Other |
| Study type | Screening |
| Participant information sheet | No participant information sheet available |
| Scientific title | Prevalence of rifampicin drug-resistant Mycobacterium tuberculosis in HIV and type 2 diabetic patients: A retrospective and cross-sectional study at endemic State Sinaloa Mexico |
| Study objectives | The prevalence of drug-resistant Mycobacterium tuberculosis (DR-MTB) in HIV and diabetic patients is higher compared with other groups affected by DR-MTB |
| Ethics approval(s) | Approved 31/05/2022, General Hospital of Culiacan Ethics Committee (Aldama & Nayarit street, Culiacan, Sinaloa, 80230, Mexico; +52-6677169810; conbioetica.contacto@salud.gob.mx); ref: 000901 |
| Health condition(s) or problem(s) studied | Prevalence of drug-resistant Mycobacterium tuberculosis (DR-MTB) in HIV and diabetic patients |
| Intervention | Data will be analysed from SINAVE, which integrates information from all over the country and from all the institutions of the National Health System (SNS). The information generated by SINAVE, is related to health, specific conditions, sociodemographic data, laboratory determination, geographical area, and previous or new pharmacological treatments, among others. The intervention of this database will be from January 2019 to February 2022 and limited to the Sinaloa State of Mexico. The following characteristics of the patients registered in the clinical files that manage to meet all the inclusion criteria for this research study will be recorded and grouped, the variables to be evaluated will be the following: sex, age, weight, disease other than HIV or T2DM location of the disease, institution that provides care, form of diagnosis, smoking, alcoholism and drug addiction. To calculate the prevalence of the disease, a record of the number of cases that occur in the population each year must be kept. Clinical data from TB specimens that were positive at diagnosis using the GeneXpert MTB/RIF Dx System test version 4.7 will be analyzed. |
| Intervention type | Other |
| Primary outcome measure | Prevalence of rifampicin drug-resistant Mycobacterium tuberculosis, determined by a positive diagnosis using the GeneXpert MTB/RIF Dx System test version 4.7, recorded in the SINAVE database between January 2019 and February 2022 |
| Secondary outcome measures | Recorded in the SINAVE database between January 2019 and February 2022: 1. Prevalence of TB/HIV, the following information will be used: p= number of events with the disease/total recorded events 2. Prevalence of TB/T2DM, the following information will be used: p= number of events with the disease/total recorded events 3. Prevalence of TB/T2DM drug resistance to rifampicin, the following information will be used: p= number of events with the disease/total recorded events 4. The correlation between suffering from the disease, HIV or T2DM with the presence of DR-TB, the prevalence ratio will be obtained and subsequently the prevalence odds ratio 5. Sociodemographic variables such as sex, age, weight, disease other than HIV or T2DM location of the disease, institution that provides care, the form of diagnosis, smoking, alcoholism and drug addiction will be recorded from the clinical history obtained from the SINAVE database |
| Overall study start date | 15/01/2022 |
| Completion date | 31/01/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 85 Years |
| Sex | Both |
| Target number of participants | The total of clinical cases, n=25,985, captured into the Database of SINAVE from january 2019 to february 2022, 3602 positive cases were recorded |
| Total final enrolment | 391 |
| Key inclusion criteria | 1. Aged between 18-85 years old 2. Populations with HIV or T2DM 3. Positive diagnosis in the state of Sinaloa in the period 2019-2021 of pulmonary Mycobacterium tuberculosis |
| Key exclusion criteria | 1. Aged 17 years old and under 2. Aged 86 years old and over 3. Extrapulmonary Mycobacterium tuberculosis diagnosis 4. Diagnosis in the other States of México 5. Diagnosis prior to 2019 or after 15 February 2022 6. Clinical cases HIV-TB and T2DM-TB not diagnosed with GeneXpert technique |
| Date of first enrolment | 02/06/2022 |
| Date of final enrolment | 31/12/2022 |
Locations
Countries of recruitment
- Mexico
Study participating centres
Rincon del Humaya
Culiacan, Sinaloa
80020
Mexico
Ciudad Universitaria
Burocrata
Culiacan, Sinaloa
80030
Mexico
Bonanza
Culiacan, Sinaloa
80020
Mexico
Sponsor information
University/education
Calz de las Americas Nte 2771
Ciudad Universitaria
Burocrata
Culiacán
80030
Mexico
| Phone | +52 6677137860 |
|---|---|
| mcb@uas.edu.mx | |
| Website | http://web.uas.edu.mx/web/ |
"ROR" |
https://ror.org/05g1mh260 |
Government
Boulevard Alfonso Zaragoza Maytorena No. 2204
Fracc
Bonanza
Culiacán Rosales
80020
Mexico
| Phone | +52 6677587000 |
|---|---|
| tuberculosis@saludsinaloa.gob.mx | |
| Website | http://saludsinaloa.gob.mx/ |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- Consejo Nacional de Ciencia y Tecnología, National Council of Humanities, Sciences and Technologies, Mexican National Council of Science and Technology, National Council for Science and Technology (CONACyT), National Council of Science and Technology, Mexico, Conahcyt
- Location
- Mexico
Results and Publications
| Intention to publish date | 01/10/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available as the SINAVE database is the property for the exclusive use of the National Epidemiological Surveillance System |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 22/04/2024 | 25/04/2024 | Yes | No |
Editorial Notes
25/04/2024: Publication reference added.
19/07/2023: The intention to publish date has been changed from 01/07/2023 to 01/10/2023.
29/12/2022: The final enrolment number has been added.
13/12/2022: Sponsor details updated.
29/07/2022: Trial's existence confirmed by the General Hospital of Culiacan Ethics Committee.
