Clinical Trial: 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

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional



Official Title: Comparison of Antibiotic Therapy Alone or Combined With Corticosteroids for the Treatment of Nontuberculous Mycobacterial Cervicofacial Lymphadenitis in Children: A Random

Brief Summary:

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 tuberculou