Nontuberculous Mycobacterial Lymphadenitis. Clinical Trial
Official title:
Comparison of Antibiotic Therapy Alone or Combined With Corticosteroids for the Treatment of Nontuberculous Mycobacterial Cervicofacial Lymphadenitis in Children: A Randomized Double-Blind Placebo-Controlled Study
| Verified date | August 2011 |
| Source | Rabin Medical Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Israel: Ministry of Health |
| Study type | Interventional |
Nontuberculous mycobacteriae (NTM) are a group of bacteria that typically cause infections
of lymph nodes in the neck and face of otherwise healthy children.
There are currently 3 strategies to manage these infections. Yet, all are not "ideal" and
each has downsides.
1. Surgery: removal of the affected lymph nodes is the most common approach but has the
disadvantages of potential facial nerve paralysis, the possibility of recurrent
infection that would require another operation and resolution with a cosmetically
disturbing scar.
2. Antibiotics: The antibiotic courses are prolonged and are associated frequently with
adverse reactions. It is unclear if this treatment has a significant effect on the
"natural" resolution process of the infection.
3. Observation: follow-up the healing process without intervention. However the resolution
may last a long period of time even more than a year. In almost all cases there will be
spontaneous discharge of pus from the involved lymph nodes onto the skin that may last
a few days. Later on a scar will form that may also be disturbing cosmetically.
The inflammatory response of the body to infections may occasionally be severe. As a matter
of fact its harmful consequences can be sometimes more serious than those of the bacteria
that cause the infection. Prednisone and other anti inflammatory drugs have properties that
could possibly prevent this.
There is medical experience in using prednisone and similar drugs in addition to antibiotics
in infectious diseases to decrease the inflammatory response against the infection. One of
these infections is tuberculosis. The tuberculous bacteria have some common features with
the nontuberculous mycobacteria. The investigators believe that the inflammatory process in
infected lymph nodes with nontuberculous mycobacteria is the major cause for the discharge
from the skin which later leads to the formation of a scar and to the prolonged resolution
from the infection. Thus in order to hasten the resolution and to avoid formation of a neck
or facial scar with its cosmetic consequences we suggest the use of prednisone in treating
nontuberculus mycobacteria lymph nodes infections. Since prednisone depresses the
inflammatory process as well as the immunity response, we chose to study the effect of
prednisone combined with antibiotics (as the later will help to overcome the bacteria).
The purpose of the study is to determine whether the addition of prednisone to antibiotic
treatment of nontuberculous mycobacteria lymph nodes infections in the neck and face of
children can hasten the resolution process and improve its cosmetic results.
The diagnosis of nontuberculous mycobacteria lymph node infection will be based on evidence
of bacterial growth in culture or on the presence of DNA of the bacteria in pus obtained
from the involved lymph nodes by fine needle aspiration.
Generally healthy children with evidence of infection will be offered to participate in the
study. They will be randomly assigned into the following 2 groups for 8 weeks treatment:
1. Antibiotics (2 types) and prednisone.
2. Antibiotics (2 types) and placebo (a material that tastes and look like prednisone but
does not have any medical effect).
Prednisone will be given in a dose that will decrease into half twice: after 2 and after
four weeks.
Follow-up visits for monitoring the inflammatory process and its resolution as well as
adverse reactions will be done around 2 weeks, 4 weeks 3 months and 6-8 months after
beginning therapy,
Blood tests and chest X-rays will be taken prior to the beginning of treatment. Blood tests
will be also taken at the first follow-up visit.
A photo of the face neck and the site of the involved lymph nodes will be taken before
starting therapy and at each of the follow-up visit.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | May 2014 |
| Est. primary completion date | May 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 3 Months to 20 Years |
| Eligibility |
Inclusion Criteria: - children aged 3 months to 20 years treated for laboratory-proven subacute/chronic NTM lymphadenitis. Exclusion Criteria: - congenital or acquired immunodeficiency - chronic disease, such as diabetes mellitus, chronic renal failure, chronic liver disease, inflammatory bowel disease, or chronic arthritis - immunosuppressive drug use (except inhaled steroids) - elevated hepatocellular enzyme levels (more than twice the upper limit of normal) - clinical suspicion of tuberculosis or a first-degree relative with tuberculosis. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Rabin Medical Center |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Resolution process of the involved lymph nodes | The primary end points of the study will be the color of the overlying skin, lymph node consistency, formulation of a fistula, and lesion area at the second and third follow-up visits. | 3 years | No |
| Secondary | Adverse reaction to the medication | The secondary end point will be any adverse reaction to the medication | 3 years. | Yes |