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Surgical excision versus antibiotic treatment for non-tuberculous mycobacterial cervicofacial lymphadenitis in children (CHIMED): a multicentre randomised controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN48902136
Enrollment
100
Registered
2006-02-08
Start date
2001-09-01
Completion date
Unknown
Last updated
2015-01-13

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

Conditions

Chronic cervicofacial lymphadenitis Circulatory System Lymphadenitis

Interventions

To compare surgical excision of involved lymph nodes with antibiotic therapy consisting of a three-month course of Clarithromycin and Rifabutin.

Sponsors

The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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. Inclusion criteria: 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

Exclusion criteria: Excluded were immunocompromised patients and patients using immunosuppressive drugs.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Secondary outcome measures were surgical complications and side effects of the medication.

Countries

Netherlands

Outcome results

None listed

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