Surgical excision versus antibiotic treatment for non-tuberculous mycobacterial cervicofacial lymphadenitis in children (CHIMED): a multicentre randomised controlled trial
Completed
- Conditions
- Chronic cervicofacial lymphadenitisCirculatory SystemLymphadenitis
- Registration Number
- ISRCTN48902136
- Lead Sponsor
- The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
Children between 0 - 15 years old with a possible NTM lymphadenitis were referred by pediatricians, otolaryngologists, oral and maxillofacial surgeons and general practitioners from all over the country.
an enlarged cervicofacial lymphadenitis for a period longer than three weeks, with negative serology for other infectious causes of chronic lymphadenitis (Cytomegalo Virus [CMV], Epstein-Barr Virus [EBV], adenovirus, bartonella and toxoplasmosis).
Exclusion Criteria
Excluded were immunocompromised patients and patients using immunosuppressive drugs.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary endpoint was cure, defined as regression of the enlarged lymph node by at least 75%, with cure of the fistula and total skin closure without local recurrence or de novo lesions at six months, as assessed by clinical and ultrasound evaluation.
- Secondary Outcome Measures
Name Time Method Secondary outcome measures were surgical complications and side effects of the medication.