Cat-scratch DiseasePhase 4NCT01469702

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

A Phase 4 study testing prednison and azithromycin, prednison, azithromycin and prednison, Azenil in people with Cat-scratch Disease and Bartonella Infections, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Ages 14 to 60 years
Conditions the study is for: Cat-scratch Disease, Bartonella Infections
What is being tested?: prednison and azithromycin, prednison, azithromycin and prednison, Azenil
How many people: 10 participants
Where: 1 siteIsrael
Study dates: Dec 2011to Aug 2012
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 14 to 60 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

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

Who cannot join

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.

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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.

Trial locations and contacts

1 site in 1 country.

Israel1 site

The Infectious Disease Unit, Tel Aviv Medical Center
Tel Aviv, 64239

Other trials in Israel

About this study

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.

Conditions: Cat-scratch Disease, Bartonella Infections
Being tested: prednison and azithromycin, prednison, azithromycin, prednison, Azenil
Keywords: cat-scratch disease, Bartonella henselae, corticosteroids, treatment
Medical subject headings: Cat-Scratch Disease, Bartonella Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

prednison and azithromycinDrug
Patients with typical cat-scratch disease will be treated with a 5-day course of prednison and azithromycin.
prednison, azithromycinDrug
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, AzenilDrug
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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Change from baseline in LS until 75% and 90% reduction in LS

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2011Aug 2012

First posted10 Nov 2011 (estimated)
Study startDec 2011
Primary completionAug 2012 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Cat-scratch DiseaseStudies of the same condition, open and under way.
More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 10 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01469702
Sponsor's protocol ID: TASMC-11-MG-0232-11-TLV-CTIL
Status last verified: Nov 2011
First submitted: 13 Sep 2011
Last updated: 11 Nov 2011
Results posted: No
Data monitoring committee: No

Study at a glance

From the registry record, last updated by the sponsor on 11 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Open Label Study of Prednisone and Azithromycin in the Treatment of Patients With Cat Scratch Disease
ClinicalTrials.gov ID: NCT01469702
Acronym / sponsor ID: TASMC-11-MG-0232-11-TLV-CTIL
Conditions: Cat-scratch Disease, Bartonella Infections
Keywords: cat-scratch disease, Bartonella henselae, corticosteroids, treatment
Phase: Phase 4
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 10 participants (estimated)
Lead sponsor: Tel-Aviv Sourasky Medical CenterOther government
Study start: Dec 2011
Primary completion: Aug 2012 (estimated)
First posted: 10 Nov 2011 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)

Who may qualify

Ages: 14 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (6 listed)

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.

Key exclusion criteria (15 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
prednison and azithromycinPatients with typical cat-scratch disease will be treated with a 5-day course of prednison and azithromycin.	Drug	–
prednison, azithromycinCap 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, AzenilCap 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.	Drug	–

Primary outcome

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.

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2011.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 11 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Severity score of lymphadenitis using a lymphadenitis Score (LS). (time frame: Change from baseline in LS until 75% and 90% reduction in LS). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01469702.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Nov 2011.