Skin InfectionPhase 2CG400549NCT01593761

Phase 2a Study of CG400549 for the Treatment of cABSSSI Caused by Methicillin-resistant Staphylococcus Aureus

A Phase 2 study testing CG400549 in people with Skin Infection, run by CrystalGenomics, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Primary Objective: To make a preliminary assessment of the efficacy of CG400549 (960 mg daily) in subjects with cABSSSI (major cutaneous abscesses) due to MRSA. Secondary Objective(s): To assess the pharmacokinetics of CG400549 (960 mg daily) in subjects with cABSSSI due to MRSA To explore the in vitro susceptibility… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Skin Infection
What is being tested?: CG400549
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteUnited States
Study dates: Jun 2012to Oct 2012
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Diagnosis of major cutaneous abscess suspected or confirmed to be caused by a MRSA.
Signs and symptoms should include at least 2 of the following: purulent drainage or discharge, erythema, fluctuance, heat or localized warmth, edema/induration, pain or tenderness to palpation

Who cannot join

Prior systemic or topical antibacterial therapy
Severe sepsis or refractory shock

Trial locations and contacts

1 site in 1 country.

United States1 site

eStudysite
La Mesa, California, 91942

Other trials in United States

About this study

Official title: Phase 2a, Repeated-dose, Open-label, Single-arm Study of CG400549 for the Treatment of Complicated Acute Bacterial Skin and Skin Structure Infection (cABSSSI) Caused by Methicillin-resistant Staphylococcus Aureus (MRSA)

Primary Objective:

To make a preliminary assessment of the efficacy of CG400549 (960 mg daily) in subjects with cABSSSI (major cutaneous abscesses) due to MRSA.

Secondary Objective(s):

To assess the pharmacokinetics of CG400549 (960 mg daily) in subjects with cABSSSI due to MRSA
To explore the in vitro susceptibility of cABSSSI-related bacteria to CG400549.
To assess the safety of multiple doses of CG400459

Read the detailed description

This will be an open-label, exploratory study to evaluate the safety, pharmacokinetics, and efficacy of CG400549, daily for 10 to 14 days, in subjects with cABSSSI (major cutaneous abscesses) due to MRSA. All subjects will receive active treatment.

Subjects will begin study treatment upon confirmation of clinical eligibility (ie, confirmation of MRSA infection is not required pretreatment). Subjects who begin treatment with CG400549 and are subsequently not found to have S. aureus infection will be discontinued from study treatment, treated as appropriate for the identified pathogen(s), and followed for safety. These subjects will be included in the safety analyses but not in the primary efficacy analysis.

Conditions: Skin Infection
Being tested: CG400549
Keywords: cABSSSI, MRSA
Medical subject headings: Cellulitis

What participants receive

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

CG400549Drug
960mg QD at fed state approx 1 hour after meal

Study groups in NCT01593761
Study group	Role	What they receive
Single Arm for CG400549	Experimental	All the patients will be administered with CG400549. Receives: Drug: CG400549

What is being measured

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

Status of Subject's Clinical Responses
Stable/improving infection, as defined by the Investigator assessment, was defined as cessation of the spread of the redness, edema, and/or induration of the lesion or reduction in the size (length, width, and shortest distance from the peripheral margin of the abscess) of redness, edema, and/or induration and absence of fever (< 37.7 °C)
Measured: Early Clinical Evaluation (ECE, 48 to 72 hours after enrollment)

Secondary outcomes (4)

Status of Subject's Clinical Response
1. Clinical cure was defined as absence of fever (< 37.7°C); presence of granulation or wound healing; resolution of pain; and decreased or resolved erythema, edema,induration, and color. Ulceration could persist, but lesions had to appear non-infected to be defined as clinical cure.
2. Clinical improvement was defined as moderate resolution of 2 or more clinical symptoms.
3. clinical failure was defined as persistence or progression of baseline signs and symptoms of cABSSSI, development of new signs and symptoms consistent with Gram-positive infection, or inability to complete the study because of AEs
Measured: End of Treatment (EOT, 10-14 days after beginning treatment) and Test of Cure (TOC, 21-28 days after beginning treatment)
Status of Subject's Microbial Eradication Response
1. Microbial eradication was defined by culture (complete absence of all infecting organisms identified at baseline) or presumed because of an absence of clinical symptoms.
2. Microbiological Persistence was defined as the presence of one or more of the original infecting organisms on the TOC culture or as the absence of cultures in case of clinical failure.
3. Microbiological Recurrence was defined as the presence on the final culture of an original infecting organism whose eradication had been either documented or presumed a the end of therapy.
Measured: End of Treatment (EOT, 10-14 days after beginning treatment) and Test of Cure (TOC, 21-28 days after beginning treatment)
Overall Summary of Adverse Events
Treatment-Emergent Adverse Event (TEAE) are those that
1. Emerging during treatment, having been absent pre-treatment or
2. Reemerge during treatment, having been present at baseline but stopped prior to treatment or
3. Worsen in severity during treatment relative to the pre-treatment state, when the adverse event is continuous.
Measured: From time of signing the informed consent to Test of Cure (TOC, 21-28 days after after beginning treatment)
Mean Plasma Concentration-time Profile of CG400549
The concentrations of CG400549 in plasma collected at each point were analyzed and calculated for its mean plasma concentration.
Measured: Day 1 predose, Day 1 1hour, Day 1 2hour, Day 1 4hour

Timeline

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

Jun 2012Oct 2012

First posted8 May 2012 (estimated)
Study startJun 2012
Primary completionSep 2012
Study completionOct 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Skin InfectionStudies of the same condition, open and under way.
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 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01593761
Sponsor's protocol ID: CG400549-2-01
Acronym: CG400549
Status last verified: Aug 2022
First submitted: 6 May 2012
Last updated: 10 Sep 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Skin Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 2a, Repeated-dose, Open-label, Single-arm Study of CG400549 for the Treatment of Complicated Acute Bacterial Skin and Skin Structure Infection (cABSSSI) Caused by Methicillin-resistant Staphylococcus Aureus (MRSA)
ClinicalTrials.gov ID: NCT01593761
Acronym / sponsor ID: CG400549 / CG400549-2-01
Conditions: Skin Infection
Keywords: cABSSSI, MRSA
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: CrystalGenomics, Inc.Industry (pharma, biotech, devices)
Study start: Jun 2012
Primary completion: Sep 2012 (actual)
Study completion: Oct 2012 (actual)
First posted: 8 May 2012 (estimated)
Results: Posted 6 Jul 2022

Clinical summary

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

Primary Objective:

To make a preliminary assessment of the efficacy of CG400549 (960 mg daily) in subjects with cABSSSI (major cutaneous abscesses) due to MRSA.

Secondary Objective(s):

To assess the pharmacokinetics of CG400549 (960 mg daily) in subjects with cABSSSI due to MRSA
To explore the in vitro susceptibility of cABSSSI-related bacteria to CG400549.
To assess the safety of multiple doses of CG400459

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Single Arm for CG400549	Experimental	Drug: CG400549All the patients will be administered with CG400549.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Diagnosis of major cutaneous abscess suspected or confirmed to be caused by a MRSA.
Signs and symptoms should include at least 2 of the following: purulent drainage or discharge, erythema, fluctuance, heat or localized warmth, edema/induration, pain or tenderness to palpation

Key exclusion criteria (2 listed)

Prior systemic or topical antibacterial therapy
Severe sepsis or refractory shock

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
CG400549960mg QD at fed state approx 1 hour after meal	Drug	Single Arm for CG400549

Primary outcome

Status of Subject's Clinical Responses
Time frame: Early Clinical Evaluation (ECE, 48 to 72 hours after enrollment)
Stable/improving infection, as defined by the Investigator assessment, was defined as cessation of the spread of the redness, edema, and/or induration of the lesion or reduction in the size (length, width, and shortest distance from the peripheral margin of the abscess) of redness, edema, and/or induration and absence of fever (< 37.7 °C)

4 secondary outcomes

Status of Subject's Clinical Response
Time frame: End of Treatment (EOT, 10-14 days after beginning treatment) and Test of Cure (TOC, 21-28 days after beginning treatment)
Status of Subject's Microbial Eradication Response
Time frame: End of Treatment (EOT, 10-14 days after beginning treatment) and Test of Cure (TOC, 21-28 days after beginning treatment)
Overall Summary of Adverse Events
Time frame: From time of signing the informed consent to Test of Cure (TOC, 21-28 days after after beginning treatment)
Mean Plasma Concentration-time Profile of CG400549
Time frame: Day 1 predose, Day 1 1hour, Day 1 2hour, Day 1 4hour

Results and safety

Results posted to the registry on 6 Jul 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Subjects Received CG400549, MITT	20	12

Primary outcome: Status of Subject's Clinical Responses

Time frame: Early Clinical Evaluation (ECE, 48 to 72 hours after enrollment). Number. Unit: participants

Measure	Subjects Proven MRSA, mMITT n = 11
Stable/ Improving Infection	10
No Stable/ Improving Infection	1

Population analysed: Among 20 participated subjects, 11 subjects had confirmed MRSA and qualified for the mMITT population

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Serious Adverse Event(SAE) was reported from the time of signing the informed consent, and AE is recorded from the time of the first dose of study drug. AEs and SAEs were recorded until subject's last visit (TOC, day 21-28 after enrollment).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Subjects Proven MRSA, mMITT	0 of 11 (0%)	10 of 11 (90.9%)	Not reported
Subjects Received CG400549, MITT	0 of 20 (0%)	13 of 20 (65%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided

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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.

Jeffrey S. Overcash, MD principal investigator

eStudysite

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CG400549 in people with Skin Infection, run by CrystalGenomics, Inc. at 1 site in United States.

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 2 inclusion and 2 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: finished, as of the sponsor's last update on 10 Sep 2022. 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 United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Jul 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Status of Subject's Clinical Responses (time frame: Early Clinical Evaluation (ECE, 48 to 72 hours after enrollment)). 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 NCT01593761.

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 10 Sep 2022.