Status:
UNKNOWN
The Efficacy of Prednisone and Azithromycin in the Treatment of Patients With Cat Scratch Disease
Lead Sponsor:
Tel-Aviv Sourasky Medical Center
Conditions:
Cat-scratch Disease
Bartonella Infections
Eligibility:
All Genders
14-60 years
Phase:
PHASE4
Brief 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 n...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01469702
Start Date
December 1 2011
Last Update
November 11 2011
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
The Infectious Disease Unit, Tel Aviv Medical Center
Tel Aviv, Israel, 64239