The Efficacy of Prednisone and Azithromycin in the Treatment of Patients With Cat Scratch Disease
|ClinicalTrials.gov Identifier: NCT01469702|
Recruitment Status : Unknown
Verified November 2011 by Michal Roll PhD,MBA, Tel-Aviv Sourasky Medical Center.
Recruitment status was: Not yet recruiting
First Posted : November 10, 2011
Last Update Posted : November 11, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Cat-scratch Disease Bartonella Infections||Drug: prednison and azithromycin Drug: prednison, azithromycin Drug: prednison, Azenil||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Open Label Study of Prednisone and Azithromycin in the Treatment of Patients With Cat Scratch Disease|
|Study Start Date :||December 2011|
|Estimated Primary Completion Date :||August 2012|
- Drug: prednison and azithromycin
Patients with typical cat-scratch disease will be treated with a 5-day course of prednison and azithromycin.
- Drug: prednison, azithromycin
Cap Azithromycin 500 mg qd (first day), then 250 mg qd for 4 days and Tab prednison 1 mg/kg/day, not exceeding 60 mg/day, qd, for 5 days.
- Drug: prednison, Azenil
Cap Azenil 500 mg qd (first day), then 250 mg qd for 4 days and Tab prednison 1 mg/kg/day, not exceeding 60 mg/day qd, for 5 days.
- Severity score of lymphadenitis using a lymphadenitis Score (LS). [ Time Frame: Change from baseline in LS until 75% and 90% reduction in LS ]LS will evaluate the severity of lymphadenitis, using the following clinical parameters: size of lymph node in cm; pain estimated by the patient, using a 0-5 scale (0 equals no pain, 5 the most severe pain); tenderness estimated by the physician, (0 equals no tenderness, 5 the most severe tenderness); erythema of the skin overlying the affected lymph-node (0 no erythema, 1 mild erythema, 2 moderate erythema and 3 severe erythema); suppuration of a lymph node will score 5 points, no suppuration will score 0. The total score will consist of the arithmetical summation of the 5 parameters.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01469702
|The Infectious Disease Unit, Tel Aviv Medical Center|
|Tel Aviv, Israel, 64239|