Cat-scratch Disease Clinical Trial
Official title:
Open Label Study of Prednisone and Azithromycin in the Treatment of Patients With Cat Scratch Disease
Bartonella henselae is the etiologic agent of cat scratch disease (CSD). 90% of patients
present with regional lymphadenitis (typical CSD) while 10% will have disease involving
other organs, such as neuroretinitis, arthropathy, erythema nodosum, and encephalitis
(atypical CSD). In most CSD cases resolution occurs in 2 to 3 months although a prolonged
course often occurs. Data on the efficacy of antibiotic therapy in CSD is limited.
Azithromycin has been shown to have a small favorable effect in a small comparative study
and is commonly prescribed for CSD, however its overall effect is not satisfactory.
Corticosteroids may be effective in the treatment of CSD for the following reasons:
- Many experts believe that host response is involved in the pathogenesis of CSD and is
responsible for the clinical manifestations rather than the direct effect of B.
henselae. The absence of viable organisms in affected lymph nodes (in the presence of
positive PCR for B. henselae DNA), and the fact that arthritis, arthralgia and erythema
nodosum (that are often associated with autoimmune diseases) have been described in
CSD, support this concept.
- Corticosteroids have been anecdotally reported to have been administered to patients
with CSD, apparently with some success. The purpose of this study is to evaluate the
efficacy of corticosteroids in addition to azithromycin in CSD. The study hypothesis is
that corticosteroids will improve out come. Ten patients with typical CSD will be
treated with a 5-day oral course of prednisone (1 mg/kg up to 60 mg/day) and
azithromycin (500 mg on day 1 and 250 mg on days 2-5). Patients will be under followed
up for 3 months. Major outcome measures will include duration of symptoms and signs,
with particular emphasis on affected lymph node size and duration using a specific
scoring system (lymphadenitis score, LS). LS will be used to evaluate lymphadenitis at
each follow-up visit. The time period from baseline LS until 75% and 90% reduction in
LS in the treatment group will be compared with historical controls. The historical
control group will be consisted of age, sex, and clinical manifestations-matched CSD
patients who were treated with azithromycin without corticosteroids.
n/a
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT03132116 -
Intra-nodal Injection of Gentamicin for the Treatment of Suppurated Cat Scratch Disease's Lymphadenitis
|
Phase 3 |