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
Contact information
Dr Jerome Lindeboom
Scientific
Scientific
A1-1
Meibergdreef 9
Department of Oral and Maxillofacial Surgery
Academic Medical Center
Amsterdam
1105 AZ
Netherlands
Study information
| Study design | Randomised, multicentre clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Scientific title | |
| Study acronym | CHIMED |
| Study objectives | 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(s) | Ethics approval received from Medical Ethics Committee (MEC) ont he 1st November 2001 (ref: 00/182). |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Clarithromycin, rifabutin |
| Primary outcome measure | 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 study start date | 01/09/2001 |
| Completion date | 01/12/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 0 Years |
| Upper age limit | 15 Years |
| Sex | Both |
| Target number of participants | 100 patients with NTM cervical lymphadenitis |
| Key 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). |
| Key exclusion criteria | Excluded were immunocompromised patients and patients using immunosuppressive drugs. |
| Date of first enrolment | 01/09/2001 |
| Date of final enrolment | 01/12/2004 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
A1-1
Amsterdam
1105 AZ
Netherlands
1105 AZ
Netherlands
Sponsor information
The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)
Research organisation
Research organisation
Laan van Nieuw Oost-Indie 334
Den Haag
2509 AE
Netherlands
| Phone | +31 (0)70 3495259 |
|---|---|
| bijlsma@zonmw.nl | |
| Website | http://www.zonmw.nl |
"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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not 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 |
