A Phase 2 interventional study of CG400549 in Skin Infection, sponsored by CrystalGenomics, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-09-10.
Sponsored by CrystalGenomics, Inc. · Phase 2, Interventional, and Treatment
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):
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.
160 studies on the registry are indexed under Cellulitis; 14 are open to participants now.
This study's enrollment of 20 is below the median of 157 across 124 interventional studies indexed under Cellulitis.
Browse Cellulitis studies →CrystalGenomics, Inc. is the lead sponsor of 17 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All the patients will be administered with CG400549.
Drug: CG400549
960mg QD at fed state approx 1 hour after meal
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)
Time frame: Early Clinical Evaluation (ECE, 48 to 72 hours after enrollment)
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
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
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.
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
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.
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
The concentrations of CG400549 in plasma collected at each point were analyzed and calculated for its mean plasma concentration.
Time frame: Day 1 predose, Day 1 1hour, Day 1 2hour, Day 1 4hour
Subjects with complicated acute bacterial skin and skin structure infection were recruited. Study was conducted from June 2012 to October 2012 at 1 site in the United States.
| Milestone | Subjects Received CG400549, MITT |
|---|---|
| Started | 20 |
| Completed | 12 |
| Not completed | 8 |
| Withdrew: Lost to follow-up | 1 |
| Withdrew: Culture negative for mrsa at baseline | 5 |
| Withdrew: Positive for hepatitis c virus | 1 |
| Withdrew: Secondary cellulitis | 1 |
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)
| participants | Subjects Proven MRSA, mMITT |
|---|---|
| Stable/ Improving Infection | 10 |
| No Stable/ Improving Infection | 1 |
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
| participants | Subjects Proven MRSA, CE |
|---|---|
| Clinical Cure at EOT | 8 (51.8 to 99.7) |
| Clinical Improvement at EOT | 1 (66.4 to 100) |
| Clinical Failure at EOT | 0 |
| Clinical Cure at TOC | 9 |
| Clinical Improvement at TOC | 0 |
| Clinical Failure at TOC | 0 |
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.
No measurements were reported for this outcome.
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.
| participants | Subjects Received CG400549, MITT | Subjects Proven MRSA, mMITT |
|---|---|---|
| Treatment-Emergent Adverse Event (TEAE) | 13 | 10 |
| Severe TEAE | 0 | 0 |
| Treatment-Related TEAE | 7 | 5 |
| Severe Treatment-Related TEAE | 0 | 0 |
| TEAE with outcome of death | 0 | 0 |
| TEAE leading to withdrawal of study medic | 0 | 0 |
| Serious Adverse Event | 0 | 0 |
The concentrations of CG400549 in plasma collected at each point were analyzed and calculated for its mean plasma concentration.
| ng/mL | Subjects Proven MRSA, mMITT |
|---|---|
| Day 1 predose | 32.921 ± 101.5 |
| Day 1 1hour | 426.921 ± 488.5 |
| Day 1 2hour | 1,366.159 ± 1028.8 |
| Day 1 4hour | 1,618.997 ± 782.3 |
Collected over 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).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Subjects Proven MRSA, mMITT | — | 0/11 (0%) | 10/11 (90.9%) |
| Subjects Received CG400549, MITT | — | 0/20 (0%) | 13/20 (65%) |
| Event | Subjects Proven MRSA, mMITT | Subjects Received CG400549, MITT |
|---|---|---|
| infectionInfections and infestations | 2/11 | 2/20 |
| tachycardiaCardiac disorders | 2/11 | 2/20 |
| pyrexiaGeneral disorders | 2/11 | 2/20 |
| headacheNervous system disorders | 2/11 | 2/20 |
| lipase increasedInvestigations | 1/11 | 3/20 |
| subcutaneous abscessInfections and infestations | 1/11 | 2/20 |
| amylase increasedInvestigations | 1/11 | 2/20 |
| cellulitisInfections and infestations | 1/11 | 1/20 |
| impetigoInfections and infestations | 1/11 | 1/20 |
| injection site cellulitisInfections and infestations | 1/11 | 1/20 |
| Age, Categorical(Participants) | Subjects Received CG400549, MITT |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 19 |
| >=65 years | 1 |
| Age, Continuous(years) | Subjects Received CG400549, MITT |
|---|---|
| Mean | 35.2 ± 13.27 |
| Sex: Female, Male(Participants) | Subjects Received CG400549, MITT |
|---|---|
| Female | 5 |
| Male | 15 |
| Region of Enrollment(participants) | Subjects Received CG400549, MITT |
|---|---|
| United States | 20 |
Plan to share: Undecided
No publications or documents are linked to this record.
The record gives a start of Jun 2012, a primary completion of Sep 2012 and a completion of Oct 2012. It does not say whether these dates are actual or estimated.
Results were first posted in Jul 2022, 9 years 10 months after primary completion.
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This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: CG 400549
CrystalGenomics, Inc.