Latent tuberculosis infection (LTBI)
Conditions
Interventions
1PaP group:Oral administration of pasiniazid plus rifapentine once daily for 28 days.
1HP group:Oral administration of isoniazid plus rifapentine once daily for 28 days.
Sponsors
The Third People’s Hospital of Shenzhen
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) Age >=18 years, male or non-pregnant, non-lactating female. Female participants of childbearing potential must have a negative serum or urine pregnancy test within 30 days prior to enrollment. (2) No radiological evidence of active tuberculosis on chest X-ray or chest CT performed within 30 days prior to enrollment. (3) Eligible for tuberculosis preventive treatment (TPT) according to the WHO Consolidated Guidelines on Tuberculosis, Module 1 (2020 Edition) or the Technical Specifications for Tuberculosis Prevention and Control in China (2020 Edition): Individuals aged >=18 years who have had close contact with a pulmonary tuberculosis patient and have positive immunologic evidence of TB infection (any of PPD, EC skin test, or IGRA). (4) Voluntarily agrees to participate and signs the written informed consent form. (5) No plan for pregnancy (including conception, sperm donation, or in vitro fertilization) during the preventive treatment period and within 6 months after treatment completion.
Exclusion criteria
Exclusion criteria: (1) Confirmed or clinically diagnosed tuberculosis, including pulmonary and extrapulmonary TB. (2) Suspected tuberculosis. (3) History of contact with a drug-resistant TB case prior to enrollment, including isoniazid-resistant TB, rifampicin-resistant TB, multidrug-resistant TB (MDR-TB), pre-extensively drug-resistant TB (pre-XDR-TB), or extensively drug-resistant TB (XDR-TB). Participants will also be excluded if the index case is later found to have drug-resistant TB after enrollment. (4) History of anti-TB drug use within 2 years prior to enrollment: continuous use of isoniazid or pasiniazid for =30 days, or rifamycin-class antibiotics for >=14 days. (5) Known hypersensitivity or intolerance to the study drug or its formulation components. (6) Current use of medications with significant drug–drug interactions with the study drug. (7) Alcohol dependence, defined as an average weekly alcohol intake >=14 g (equivalent to >=14 standard drinks; one standard drink contains 14 g of alcohol, e.g., 360 mL of beer, 45 mL of 40% spirits, or 150 mL of wine). (8) Abnormal liver function or liver disease, including any of the following (based on laboratory parameters within 30 days prior to enrollment): Serum ALT or AST >3× upper limit of normal (ULN); Total bilirubin >2.5× ULN; History of liver cirrhosis; Ongoing antiviral therapy for viral hepatitis; Clinical signs suggestive of acute hepatitis within 90 days prior to enrollment (e.g., abdominal pain, jaundice, vomiting). (9) Severe hematologic disorders, including any of the following (based on laboratory parameters within 30 days prior to enrollment): Absolute neutrophil count <0.75×10?/L; Platelet count <50×10?/L; Hemoglobin <70 g/L. (10) Peripheral neuropathy = Grade 2, according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. (11) Body weight <25.0 kg. (12) HIV infection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment completion rate (adherence) among different drug regimens;Incidence of adverse events (safety); | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of serious adverse events (SAEs);Incidence of grade 3–4 adverse events related to anti-tuberculosis drugs;Discontinuation rate due to adverse drug reactions;Overall mortality and non-tuberculosis mortality;Cumulative incidence and incidence density of tuberculosis (efficacy); | — |
Countries
China
Contacts
Public ContactLu Shuihua
The Third People’s Hospital of Shenzhen
Outcome results
None listed