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Rifampicin Versus Rifampicin, Isoniazid, Ethambutol for the Treatment of non-puerperal mastitis: A randomized, non-inferiority, multicenter clinical study

Rifampicin Versus Rifampicin, Isoniazid, Ethambutol for the Treatment of non-puerperal mastitis: A randomized, non-inferiority, multicenter clinical study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400083783
Enrollment
Unknown
Registered
2024-05-01
Start date
2024-05-01
Completion date
Unknown
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

non-puerperal mastitis

Interventions

Rifampicin treatment group:Rifampicin 450mg/d
Rifampicin, isoniazid, ethambutol treatment group:rifampicin (450 mg/day), isoniazid (300 mg/day) and ethambutol (750 mg/day)

Sponsors

The Second Hospital of Shandong University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
15 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Female patients aged 18-75 years; 2. Primary patients with histopathologically confirmed GLM or PDM; 3. ECOG score: 0-1; 4. No pregnancy planned within 3 years; 5. Voluntary enrolment in the study and signed informed consent form

Exclusion criteria

Exclusion criteria: 1. Previous history of tuberculosis; 2. History of isoniazid, rifampicin, or ethambutol administration; 3. Pathology that fails to clarify GLM or PDM or other combined breast infections 4. Abnormalities of the blood system, liver and kidney functions; 5. Severe heart, liver, lung, kidney etc. dysfunction 6. History of uncontrolled diabetes mellitus or hypertension; 7. History of mental illness 8. History of malignant tumour 9. Women who are pregnant or breastfeeding 10. Other subjects who are not suitable to participate in this study.

Design outcomes

Primary

MeasureTime frame
Cure rate;Remission rate;Recurrence rate;Quality of life;

Secondary

MeasureTime frame
Incidence of adverse events;

Countries

China

Contacts

Public ContactZhigang Yu

The Second Hospital of Shandong University

yzg@medmail.com.cn+86 531 8587 5048

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026