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Inicio Enfermedades Infecciosas y Microbiología Clínica Executive summary: Clinical practice guidelines on the management of resistant t...
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Vol. 42. Issue 10.
Pages 588-596 (December 2024)
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Vol. 42. Issue 10.
Pages 588-596 (December 2024)
Consensus document
Executive summary: Clinical practice guidelines on the management of resistant tuberculosis of the Spanish Society of Pulmonology and Thoracic Surgery (SEPAR) and the Spanish Society of Infectious Diseases and Clinical Microbiology (SEIMC)
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Adrian Sanchez-Montalvaa,b,c,1,
Corresponding author
, José Antonio Caminerod,e,1, Mª Remedio Gunaf,g,h, Teresa Rodrígo Sanzi, Ramón Rabuñalj,b, Joan Pau Milletk,l,m,n, José Antonio Gullón-Blancoo, Luis Anibarrop,q, Guillermo Perez-Mendozar,s, Juan Francisco Medinat,u, Verónica González-Galánv,w,2, Eva Tabernerox,y,2, on behalf of the Writing committee of the Spanish MDR TB consortium (in alphabetical order)
a International Health Unit Vall d’Hebron-Drassanes, Infectious Diseases Department, Vall d’Hebron University Hospital, PROSICS Barcelona, Autonomous University of Barcelona, Spain
b Mycobacterial Infections Study Group (GEIM) of the Spanish Society of Infectious Diseases and Clinical Microbiology (SEIMC), Madrid, Spain
c For Biomedical Research Centre in Infectious Diseases Network (CIBERINFEC), Carlos III Health Institute, Madrid, Spain
d Prof. Head of the Pulmonology Service at the Dr. Negrín General University Hospital, Las Palmas de GC, Spain
e Director of Scientific Activities ALOSA TB ACADEMY, Spain
f Microbiology Service, General University Hospital Consortium of Valencia, Valencia, Spain
g Department of Microbiology and Parasitology, Faculty of Medicine, University of Valencia, Mycobacterial Infections Study Group (GEIM) of the Spanish Society of Infectious Diseases and Clinical Microbiology (SEIMC), Madrid, Spain
h SEIMC Quality Control, Madrid, Spain
i Integrated Research Program in Tuberculosis and Non-Tuberculous Mycobacteria (PII-TB&MNT), Centre for Biomedical Research in Public Health Network (CIBERESP), Barcelona Tuberculosis Research Unit, Spain
j Infectious Diseases Unit, Internal Medicine Department, Lucus Augusti University Hospital, Lugo, Spain
k Epidemiology Service, Public Health Agency of Barcelona, Barcelona, Spain
l Serveis Clínics, Barcelona, Spain
m Integrated Research Program in Tuberculosis (PII-TB) of the Spanish Society of Pneumology and Pathology of the Respiratory System (SEPAR), Barcelona, Spain
n Centre for Biomedical Research in Epidemiology and Public Health Network (CIBERESP), Carlos III Health Institute, Madrid, Spain
o Pulmonology Section, San Agustín University Hospital, Avilés, Spain
p Tuberculosis Unit, Infectious Diseases, Internal Medicine Service, University Hospital Complex, Pontevedra, Spain
q Immunology Research Group, Galicia Sur Health Research Institute, Spain
r Pulmonology Department, Dr. Negrín University Hospital of Gran Canaria, Las Palmas de GC, Spain
s PII-TB&MNT & SEPAR Study Group, Spain
t Medical-Surgical Unit of Respiratory Diseases (UMQER) Virgen del Rocío University Hospital, Seville, Spain
u Integrated Research Program in Tuberculosis and Non-Tuberculous Mycobacteria (PII-TB&MNT), Spain
v Clinical Unit of Infectious Diseases, Microbiology, and Clinical Parasitology (UCEIMP), Virgen del Rocío University Hospital, Seville, Spain
w Institute of Biomedicine of Seville (IBiS), Clinical and Molecular Microbiology Group, Mycobacteria Line, GEIM-SEIMC Study Group, PII-TB& MNT, SEPARATE, Spain
x Pulmonology Service, Cruces University Hospital (OSI EEC), Barakaldo, Spain
y BioBizkaia Health Research Institute, Spain
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Annex. Members of the Spanish MDR TB consortium group
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Tables (5)
Table 1. WHO classification of the drugs for formulating treatment for people with tuberculosis caused by a strain of M. tuberculosis resistant to some drugs used to treat drug-susceptible tuberculosis.
Table 2. Expert panel classification of drugs for formulating treatment for people affected with tuberculosis caused by a strain of M. tuberculosis resistant to some drugs used to treat drug-susceptible tuberculosis.
Table 3. Recommended doses of drugs used in the treatment tuberculosis caused by a strain of M. tuberculosis resistant to some drugs used to treat drug-susceptible tuberculosis.
Table 4. Monitoring proposal for people affected by RR/MDR-TB under treatment.
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Additional material (1)
Abstract

The Spanish Society of Pneumology and Thoracic Surgery (SEPAR) and the Spanish Society of Infectious Diseases and Clinical Microbiology (SEIMC) have developed together Clinical Practice Guidelines (GPC) on the management of people affected by tuberculosis (TB) resistant to drugs with activity against Mycobacterium tuberculosis. These clinical practice guidelines include the latest updates of the SEPAR regulations for the diagnosis and treatment of drug-resistant TB from 2017 to 2020 as the starting point. The methodology included asking relevant clinical questions based on PICO methodology, a literature search focusing on each question, and a systematic and comprehensive evaluation of the evidence, with a summary of this evidence for each question. Finally, recommendations were developed and the level of evidence and the strength of each recommendation for each question were established in concordance with the GRADE approach. Of the recommendations made, it is worth highlighting the high quality of the existing evidence for the use of nucleic acid amplification techniques (rapid genotypic tests) as initial tests for the detection of the M. tuberculosis genome and rifampicin resistance in people with presumptive signs or symptoms of pulmonary TB; and for the use of an oral combination of anti-TB drugs based on bedaquiline, delamanid (pretomanid), and linezolid, with conditional fluoroquinolone supplementation (conditioned by fluoroquinolone resistance) for six months for the treatment of people affected by pulmonary multidrug-resistant tuberculosis (MDR-TB). We also recommend directly observed therapy (DOT) or video-observed treatment for the treatment of people affected by DR-TB.

Keywords:
Bedaquiline
Delamanid
Pretomanid ethambutol
Guidelines
Isoniazid
Levofloxacin
Linezolid
Moxifloxacin
Mycobacterium tuberculosis
Pyrazinamide
Recommendations
Resistance
Rifampicin
Tuberculosis
Multidrug-resistant tuberculosis
Resistant tuberculosis
MDR-TB
RR-TB
Abbreviations:
B
BSL
BPaL
BPaLC
BPaLM
CDC
CLSI
CNE
COVID-19
CPG
D
DNA
DOT
DR
DR-TB
DST
E
ECDC
ESTC
EU/EEA
FQs
GeSIDA
GRADE
H
HIV
HR
L
LTI
M
MDR
MGIT
MIC
MDR-TB
MS
MTB
MTBC
NAAT
P
PAS
PCR
PICO
PII-TB&MNT
PPV
preXDR-TB
PRISMA
R
RENAVE
RR
RR-TB
SARS-CoV-2
SEIMC
SEPAR
TB
VOT
WHO
XDR
XDR-TB
Z

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