Evidence map›Paper›PMID 39924538›Full record

ArticleBMC infectious diseases2025

Evaluation of a modified short all oral treatment regimen for rifampicin-multidrug resistant tuberculosis in Dominican Republic.

María Rodríguez, Yamile Celis Bustos, Melanea Encarnación, Elisabet Muñoz, Sandra De Los Santos, Ingrid Sánchez, Lissette Portorreal, Seydou Benjamín Sombie, Fatimata Bintou Sall, Corinne Simone Merle and 1 more

Abstract read
In one paragraph

Article in BMC infectious diseases, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 2 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Article
  4. Article
  5. Article
  6. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

María RodríguezNational Tuberculosis Program, Ministry of Health, Santo Domingo, Dominican Republic. mariarodriguez.tb@gmail.com.
Yamile Celis BustosDepartment of Communicable Diseases Prevention, Control, and Elimination, Pan American Health Organization, Washington, DC, USA.
Melanea EncarnaciónDR-TB Regional Units, National Health Service, Santo Domingo, Dominican Republic.
Elisabet MuñozDR-TB Regional Units, National Health Service, Santo Domingo, Dominican Republic.
Sandra De Los SantosDR-TB Regional Units, National Health Service, Santo Domingo, Dominican Republic.
Ingrid SánchezNational Tuberculosis Program, Ministry of Health, Santo Domingo, Dominican Republic.
Lissette PortorrealClinical Management Department, National Health Service, Santo Domingo, Dominican Republic.
Seydou Benjamín SombieSpecial Programme for Research and Training in Tropical Diseases (TDR), World Health Organization, Geneva, Switzerland.
Fatimata Bintou SallSpecial Programme for Research and Training in Tropical Diseases (TDR), World Health Organization, Geneva, Switzerland.
Corinne Simone MerleSpecial Programme for Research and Training in Tropical Diseases (TDR), World Health Organization, Geneva, Switzerland.
Freddy PerezDepartment of Communicable Diseases Prevention, Control, and Elimination, Pan American Health Organization, Washington, DC, USA.

Funding

TDR 2021/1188581-0World Health Organization 001
6 · The paper itself

Abstract

backgroundThis study aims to evaluate the effectiveness, safety, and impact on health-related quality of life (HQoL) of a fully oral shortened regimen for Rifampicin-Resistant/Multidrug-Resistant Tuberculosis (RR/MDR-TB) over 9 to 12 months under programmatic conditions.

methodsA prospective cohort study was conducted on an all-oral modified Shortened Treatment Regimen (mSTR) comprising linezolid (Lzd), bedaquiline (Bdq), levofloxacin (Lfx), clofazimine (Cfz), and cycloserine (Cs). Patients with RR/MDR-TB were enrolled between January and December 2022 across seven drug-resistant TB units in the Dominican Republic.

resultsA total of 113 patients were enrolled, with 87% achieving culture conversion at two months. Treatment outcomes revealed that 79% of patients were successfully treated and didn't relapse six months after the end of the treatment, 14% were lost to follow-up during the treatment, 6% deceased, and one experienced treatment failure due to Adverse Drug Reactions (ADRs). Adverse events of Special interest (AESI) were common, with 82% of patients experiencing at least one AE with high proportion of QT interval prolongation, elevated transaminases, and anemia. A total of 12% of the patients experiencing Serious Adverse Events (SAEs). Improvement in HQoL dimensions was noted throughout treatment, with the EQ-VAS score increasing by an average of 15.5 by treatment end.

conclusionThe high treatment success rate of the 5-drug mSTR facilitated the adaptation and integration of a shortened treatment regimen lasting 9 to 12 months in routine care in Dominican Republic. SAEs were -rare. Although AESI were frequent, they were manageable in most cases. Continuous monitoring, particularly with regard to the use of Lzd and Bdq, is crucial to effectively mitigating risks. Since September 2023, this short all oral treatment regimen is the recommended approach for patients with RR/MDR-TB in the Dominican Republic.

Indexed as

Antitubercular AgentsRifampinTuberculosis, Multidrug-ResistantAdministration, OralAdultAgedClofazimineCycloserineDiarylquinolinesDominican RepublicDrug Therapy, CombinationFemaleHumansLevofloxacinLinezolidMaleAntitubercular AgentsbedaquilineClofazimineCycloserineDiarylquinolinesLevofloxacinLinezolidRifampinBedaquilineDominican RepublicHealth-Related Quality of LifeLinezolidMultidrug-resistantSafetyShort all-oral treatmentTreatment outcomeTuberculosis

Identifiers

PMID39924538
PMCPMC11808990

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.