Condition category
Circulatory System
Date applied
01/02/2006
Date assigned
08/02/2006
Last edited
21/09/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.mycobacterie.nl

Contact information

Type

Scientific

Primary contact

Dr Jerome Lindeboom

ORCID ID

Contact details

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

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

http://www.zonmw.nl

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

  1. 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.

  2. 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.

  3. 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.

Additional files

Editorial Notes