Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
945-02-019
Study information
Scientific title
Acronym
CHIMED
Study hypothesis
Non-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
Ethics approval received from Medical Ethics Committee (MEC) ont he 1st November 2001 (ref: 00/182).
Study design
Randomised, multicentre clinical trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Treatment
Patient information sheet
Condition
Chronic cervicofacial lymphadenitis
Intervention
To compare surgical excision of involved lymph nodes with antibiotic therapy consisting of a three-month course of Clarithromycin and Rifabutin.
Intervention type
Drug
Phase
Not Specified
Drug names
Clarithromycin, rifabutin
Primary outcome measures
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
Secondary outcome measures were surgical complications and side effects of the medication.
Overall trial start date
01/09/2001
Overall trial end date
01/12/2004
Reason abandoned
Eligibility
Participant 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).
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
100 patients with NTM cervical lymphadenitis
Participant exclusion criteria
Excluded were immunocompromised patients and patients using immunosuppressive drugs.
Recruitment start date
01/09/2001
Recruitment end date
01/12/2004
Locations
Countries of recruitment
Netherlands
Trial participating centre
A1-1
Amsterdam
1105 AZ
Netherlands
Sponsor information
Organisation
The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)
Sponsor details
Laan van Nieuw Oost-Indie 334
Den Haag
2509 AE
Netherlands
+31 (0)70 3495259
bijlsma@zonmw.nl
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands) (ref: 945-02-019)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
Results in:
1. http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=16267728
2. http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=15705324
3. http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=15184446
Publication citations
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Lindeboom JA, Prins JM, Bruijnesteijn van Coppenraet ES, Lindeboom R, Kuijper EJ, Cervicofacial lymphadenitis in children caused by Mycobacterium haemophilum., Clin. Infect. Dis., 2005, 41, 11, 1569-1575, doi: 10.1086/497834.
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Bruijnesteijn van Coppenraet LE, Kuijper EJ, Lindeboom JA, Prins JM, Claas EC, Mycobacterium haemophilum and lymphadenitis in children., Emerging Infect. Dis., 2005, 11, 1, 62-68, doi: 10.3201/eid1101.040589.
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Bruijnesteijn Van Coppenraet ES, Lindeboom JA, Prins JM, Peeters MF, Claas EC, Kuijper EJ, Real-time PCR assay using fine-needle aspirates and tissue biopsy specimens for rapid diagnosis of mycobacterial lymphadenitis in children., J. Clin. Microbiol., 2004, 42, 6, 2644-2650, doi: 10.1128/JCM.42.6.2644-2650.2004.