Trial · NCT05977868
Comparing Oral Versus Parenteral Antimicrobial Therapy
NCT05977868, Phase 4, Terminated, West Virginia University; results first posted 2025-08-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Comparing Oral Versus Parenteral Antimicrobial Therapy. Trials, record NCT05977868. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05977868
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Comparing Oral Versus Parenteral Antimicrobial Therapy
- NCT number
- NCT05977868
- Status
- Terminated
- Phases
- Phase 4
- Enrollment
- 94 participants, actual
- Lead sponsor
- West Virginia University
- Conditions
- Endovascular Infection, Bone and Joint Infection, Skin and Soft Tissue Infection, Pulmonary Infection, Gastrointestinal Infection, Genitourinary Infection
- Interventions
Amoxicillin, amoxicillin-clavulanate, cefadroxil, cefpodoxime, cefalexin, ciprofloxacin, delafloxacin, doxycycline, levofloxacin, linezolid, Ampicillin, ampicillin-sulbactam, cefazolin, cefepime, ceftaroline, ceftazidime, ceftazidime-avibactam, dalbavancin, daptomycin, ertapenem
- First posted
- 2023-08-07
- Last updated
- 2025-08-26
- Results first posted
- 2025-08-26
- Limitations and caveats
Our trial was unblinded for pragmatic reasons. Assessment of clinical cure/control by 2 ID physicians blinded to study arm minimized potential bias. More patients in Experimental group had a procedure for source control. At least two ID physicians select oral regimens to optimize safety. Patients with active SUD/IDU were excluded. All patients were followed through OPAT and COpAT programs. Study results may not be generalizable to institutions/practices without these programs.
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Cure/Control at 3 Months | 3 months after hospital discharge | Number of patients with cure/control using clinical (resolution of infection - e.g., wound healed) and laboratory (improvement in inflammatory markers - e.g., CRP normalization) parameters as adjudicated by 2 ID faculty blinded to study arm |
| Primary | Adverse Events Related to Antimicrobial Therapy | Up to 3 months after hospital discharge | Number of participants with adverse events requiring intervention related to antimicrobial therapy (e.g., thrombocytopenia) |
| Primary | Adverse Events Related to Vascular Access | Up to 3 months after hospital discharge | Number of participants with adverse events requiring intervention related to vascular access complication (e.g., deep venous thrombosis) |
| Primary | Overall Readmission | Up to 3 months after hospital discharge | Number of participants readmitted for any reason up to 3 months after discharge from the hospital |
| Secondary | Number of Participants Reporting 'Satisfied' or 'Very Satisfied' on Patient Satisfaction Survey | 6 weeks after hospital discharge | Patient satisfaction using the COPAT Trial Patient Satisfaction Survey at 6 Weeks, which is a short questionnaire (with the overall satisfaction question incorporating a Likert scale 1= Very Dissatisfied, 5= Very Satisfied) designed to assess overall patient satisfaction. Overall satisfaction totaled from participants answering 4= Satisfied and 5= Very Satisfied. |
| Secondary | Number of Participants Who Answered 'Yes' to the Survey Question "Would You Have Preferred to be in the Other Study Arm? (Yes or No)" | 6 weeks after hospital discharge | The number of participants who expressed a preference to be in the other study arm (i.e., answers 'Yes' to the survey question "Would you have preferred to be in the other study arm? Yes or No"). |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Cure/Control at 3 Months | 3 months after hospital discharge | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Adverse Events Related to Antimicrobial Therapy | Up to 3 months after hospital discharge | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Adverse Events Related to Vascular Access | Up to 3 months after hospital discharge | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Overall Readmission | Up to 3 months after hospital discharge | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants Reporting 'Satisfied' or 'Very Satisfied' on Patient Satisfaction Survey | 6 weeks after hospital discharge | Four withdrew early prior to hospital discharge: 3 chose not to participate, and one transitioned to comfort care (mortality). | participants | NUMBER |
| SECONDARY | Number of Participants Who Answered 'Yes' to the Survey Question Would You Have Preferred to be in the Other Study Arm? (Yes or No) | 6 weeks after hospital discharge | Four withdrew early prior to hospital discharge: three chose not to participate, and one transitioned to comfort care (mortality). | participants | NUMBER |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Cure/Control at 3 Months | Group 1 (Experimental) | 61 | Participants | ||
| Cure/Control at 3 Months | Group 2 (Control) | 28 | Participants | ||
| Adverse Events Related to Antimicrobial Therapy | Group 1 (Experimental) | 4 | Participants | ||
| Adverse Events Related to Antimicrobial Therapy | Group 2 (Control) | 4 | Participants | ||
| Adverse Events Related to Vascular Access | Group 1 (Experimental) | 0 | Participants | ||
| Adverse Events Related to Vascular Access | Group 2 (Control) | 7 | Participants | ||
| Overall Readmission | Group 1 (Experimental) | 17 | Participants | ||
| Overall Readmission | Group 2 (Control) | 7 | Participants | ||
| Number of Participants Reporting 'Satisfied' or 'Very Satisfied' on Patient Satisfaction Survey | Group 1 (Experimental) | 60 | participants | ||
| Number of Participants Reporting 'Satisfied' or 'Very Satisfied' on Patient Satisfaction Survey | Group 2 (Control) | 27 | participants |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Group 1 (Experimental) | 64 | |
| Overall Study | STARTED | Group 2 (Control) | 30 | |
| Overall Study | COMPLETED | Group 1 (Experimental) | 62 | |
| Overall Study | COMPLETED | Group 2 (Control) | 28 | |
| Overall Study | NOT COMPLETED | Group 1 (Experimental) | 2 | |
| Overall Study | NOT COMPLETED | Group 2 (Control) | 2 |
Source ClinicalTrials.gov
Adverse events22
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Antibiotic Side Effect | General disorders | Experimental | 3 | 64 | 3 |
| other | Antibiotic Side Effect | General disorders | Control | 2 | 30 | 2 |
| other | Antibiotic Side Effect | Infections and infestations | Experimental | 1 | 64 | 1 |
| other | Antibiotic Side Effect | Infections and infestations | Control | 1 | 30 | 1 |
| other | Antibiotic Side Effect | Respiratory, thoracic and mediastinal disorders | Experimental | 0 | 64 | 0 |
| other | Antibiotic Side Effect | Respiratory, thoracic and mediastinal disorders | Control | 1 | 30 | 1 |
| other | Line Related Adverse Event | Vascular disorders | Experimental | 0 | 64 | 0 |
| other | Line Related Adverse Event | Vascular disorders | Control | 7 | 30 | 8 |
| serious | Readmission | General disorders | Experimental | 7 | 64 | 7 |
| serious | Readmission | General disorders | Control | 2 | 30 | 2 |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Experimental | 1 | 64 |
| Total, all-cause mortality | Control | 0 | 30 |
| Total, other adverse events | Experimental | 4 | 64 |
| Total, other adverse events | Control | 8 | 30 |
| Total, serious adverse events | Experimental | 18 | 64 |
| Total, serious adverse events | Control | 7 | 30 |
Source ClinicalTrials.gov
Papers6
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons8
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Group 1 (Experimental) vs Group 2 (Control): Adverse Events Related to Antimicrobial Therapy | Trial comparisons |
| Group 1 (Experimental) vs Group 2 (Control): Overall Readmission | Trial comparisons |
| Group 1 (Experimental) vs Group 2 (Control): Number of Participants Reporting 'Satisfied' or 'Very Satisfied' on Patient Satisfaction Survey | Trial comparisons |
| Group 1 (Experimental) vs Group 2 (Control): Cure/Control at 3 Months | Trial comparisons |
| Group 1 (Experimental) vs Group 2 (Control): Number of Participants Who Answered 'Yes' to the Survey Question Would You Have Preferred to be in the Other Study Arm? (Yes or No) | Trial comparisons |
| Group 1 (Experimental) vs Group 2 (Control): Adverse Events Related to Vascular Access | Trial comparisons |
| Experimental vs Control: deaths from any cause | Trial comparisons |
| Experimental vs Control: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05977868
GET https://conductscience.org/api/trials/v1/NCT05977868/events?page=2