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

ISRCTN ISRCTN48902136
DOI https://doi.org/10.1186/ISRCTN48902136
Secondary identifying numbers 945-02-019
Submission date
01/02/2006
Registration date
08/02/2006
Last edited
21/09/2007
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Dr Jerome Lindeboom
Scientific

A1-1
Meibergdreef 9
Department of Oral and Maxillofacial Surgery
Academic Medical Center
Amsterdam
1105 AZ
Netherlands

Study information

Study designRandomised, multicentre clinical trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)GP practice
Study typeTreatment
Scientific title
Study acronymCHIMED
Study objectivesNon-tuberculous mycobacteria (NTM) are a common cause of chronic cervicofacial lymphadenitis in children, especially between the age of 1 and 5 years.The disease is usually unilateral, occurring in the submandibular or preauricular area. The nodes suppurate and form a chronic sinus tract.

The optimal treatment of Non-Tuberculous Mycobacterial (NTM) cervical lymphadenitis in children has not been established. Until recently surgical excision was the standard treatment, but the number of reports of successful antibiotic treatment is increasing, questioning surgery as the preferred treatment. In this randomised, multicenter trial we compared surgical excision to antibiotic treatment.
Ethics approval(s)Ethics approval received from Medical Ethics Committee (MEC) ont he 1st November 2001 (ref: 00/182).
Health condition(s) or problem(s) studiedChronic cervicofacial lymphadenitis
InterventionTo compare surgical excision of involved lymph nodes with antibiotic therapy consisting of a three-month course of Clarithromycin and Rifabutin.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Clarithromycin, rifabutin
Primary outcome measurePrimary 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 measuresSecondary outcome measures were surgical complications and side effects of the medication.
Overall study start date01/09/2001
Completion date01/12/2004

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit0 Years
Upper age limit15 Years
SexBoth
Target number of participants100 patients with NTM cervical lymphadenitis
Key inclusion criteriaChildren 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).
Key exclusion criteriaExcluded were immunocompromised patients and patients using immunosuppressive drugs.
Date of first enrolment01/09/2001
Date of final enrolment01/12/2004

Locations

Countries of recruitment

  • Netherlands

Study participating centre

A1-1
Amsterdam
1105 AZ
Netherlands

Sponsor information

The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)
Research organisation

Laan van Nieuw Oost-Indie 334
Den Haag
2509 AE
Netherlands

Phone +31 (0)70 3495259
Email bijlsma@zonmw.nl
Website http://www.zonmw.nl
ROR logo "ROR" https://ror.org/01yaj9a77

Funders

Funder type

Research organisation

The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands) (ref: 945-02-019)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Other publications 01/06/2004 Yes No
Other publications 01/01/2005 Yes No
Other publications 01/12/2005 Yes No