The Efficacy of Prednisone and Azithromycin in the Treatment of Patients With Cat Scratch Disease

Cat-scratch Disease Clinical Trial

Official title:

Open Label Study of Prednisone and Azithromycin in the Treatment of Patients With Cat Scratch Disease

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01469702
• Other study ID #: TASMC-11-MG-0232-11-TLV-CTIL
• Status: Not yet recruiting
• Phase: Phase 4
• First received: September 13, 2011
• Last updated: November 10, 2011
• Start date: December 2011

Study information

• Verified date: November 2011
• Source: Tel-Aviv Sourasky Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 14 Years to 60 Years

Eligibility

Inclusion criteria

• Patients and/or legally authorized representative(s), if applicable, who have been fully informed and have given voluntary written informed consent OR patients unable to write and/or read but who fully understand the oral information given by the Investigator (or nominated representative) who have given oral informed consent witnessed in writing by an independent person.

• Ability and willingness to comply with the protocol.

• Male and female patients aged 14-60 years at the time of signing informed consent.

• Female patients must be non-lactating and at no risk of pregnancy for one of the following reasons: Postmenopausal (amenorrhea for at least 1 year); post hysterectomy and/or post-bilateral ovariectomy; if of childbearing potential, having a negative serum or urine human chorionic gonadotropin (hCG) pregnancy test at screening and is using a highly effective method of birth control throughout the study; reliable sexual abstinence throughout the course of the study is acceptable as a highly effective method of birth control for the purposes of this study.

• Patients with clinical manifestations consistent with early typical cat scratch disease (lymphadenitis) before spontaneous improvement has been recorded and before development of suppuration.

• Laboratory confirmation (serology and/or PCR) of cat scratch disease

Exclusion criteria

• Women who are pregnant or breastfeeding.

• Known history of allergy, hypersensitivity, or any serious reaction to azithromycin, other macrolides or corticosteroids.

• Patients for whom azithromycin or corticosteroids is contra-indicated.

• Patients at high risk for QT/QTc prolongation, e.g. Baseline prolongation of QTcF >/=500 msec; Risk factors for Torsade de Pointes (e.g. uncompensated heart failure, abnormal potassium or magnesium levels that cannot be corrected, any unstable cardiac condition during the last 30 days, or a family history of long QT syndrome); The use of concomitant medications that prolong the QT/QTc interval.

• Current treatment with systemic corticosteroids.

• Patients with typical late cat scratch disease who has demonstrated constant improvement in the clinical manifestations of the involved lymph node.

• Atypical cat scratch disease (e.g. encephalitis, pneumonitis, osteomyelitis).

• Endocarditis due to Bartonella sp..

• Diabetes mellitus.

• Peptic ulcer disease or history of upper GI bleeding.

• History of inadequately treated tuberculosis or evidence of tuberculosis in the chest radiography.

• Schizoaffective disorder, anxiety or depression treated with antipsychiatric drugs, at present or in the past.

• AIDS or positive serology for HIV.

• Absolute neutrophil count < 1000/mm3.

• Treatment with any investigational drug in any clinical trial within 30 days prior to administration of study medication.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bartonella Infections
• Cat-Scratch Disease

Intervention

Drug:
• prednison and azithromycin
Patients with typical cat-scratch disease will be treated with a 5-day course of prednison and azithromycin.
• 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.
• 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.

Locations

Country	Name	City	State
Israel	The Infectious Disease Unit, Tel Aviv Medical Center	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Severity score of lymphadenitis using a lymphadenitis Score (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.	Change from baseline in LS until 75% and 90% reduction in LS	No