Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2025-12-25 @ 3:46 AM
NCT ID:
NCT01469702
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
14 Years
Maximum Age:
60 Years
Study:
NCT01469702
Study Brief:
Protocol Section:
NCT01469702