Trial · NCT03580044
Efficacy, Safety, and Tolerability of ATM-AVI in the Treatment of Serious Infection Due to MBL-producing Gram-negative Bacteria
NCT03580044, Phase 3, Terminated, Pfizer; results first posted 2024-02-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy, Safety, and Tolerability of ATM-AVI in the Treatment of Serious Infection Due to MBL-producing Gram-negative Bacteria. Trials, record NCT03580044. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03580044
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy, Safety, and Tolerability of ATM-AVI in the Treatment of Serious Infection Due to MBL-producing Gram-negative Bacteria
- NCT number
- NCT03580044
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 15 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Serious Bacterial Infection
- Interventions
- ATM-AVI, BAT
- First posted
- 2018-07-09
- Last updated
- 2024-02-02
- Other registries' IDs
- eudract:2017-004544-38
- Results first posted
- 2024-02-02
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Clinical Cure at the Test of Cure (TOC) Visit -Microbiological Intent to Treat (Micro-ITT) Analysis Set | Day 28 | Clinical cure was defined as improvement in baseline signs and symptoms such that no further antimicrobial treatment was required for the index infection (i.e., cIAI, cUTI, HAP/VAP or BSI) after study treatment. Also for cIAI participants, no unplanned drainage or surgical intervention was necessary since the initial procedure. The clinical response assessment was determined by a blinded independent adjudication committee. 95% confidence interval (CI) was calculated using Jeffrey's method. |
| Secondary | Percentage of Participants With Clinical Cure at the TOC Visit-Microbiologically Evaluable (ME) Analysis Set | Day 28 | Clinical cure was defined as improvement in baseline signs and symptoms such that no further antimicrobial treatment was required for the index infection (i.e., cIAI, cUTI, HAP/VAP or BSI) after study treatment. Also, for cIAI participants, no unplanned drainage or surgical intervention was necessary since the initial procedure. The clinical response assessment was determined by a blinded independent adjudication committee. 95% CI was calculated using Jeffrey's method. |
| Secondary | Percentage of Participants With Clinical Cure at the End of Treatment (EOT) Visit- Micro-ITT Analysis Set | Up to 24 hours after the last infusion on Day 14 | Clinical cure was defined as improvement in baseline signs and symptoms such that no further antimicrobial treatment was required for the index infection (i.e., cIAI, cUTI, HAP/VAP or BSI) after study treatment. Also for cIAI participants, no unplanned drainage or surgical intervention was necessary since the initial procedure. The clinical response assessment was determined by a blinded independent adjudication committee. 95% CI was calculated using Jeffrey's method. |
| Secondary | Percentage of Participants With Clinical Cure at the EOT Visit- ME Analysis Set | Up to 24 hours after the last infusion on Day 14 | Clinical cure was defined as improvement in baseline signs and symptoms such that no further antimicrobial treatment was required for the index infection (i.e., cIAI, cUTI, HAP/VAP or BSI) after study treatment. Also for cIAI participants, no unplanned drainage or surgical intervention was necessary since the initial procedure. The clinical response assessment was determined by a blinded independent adjudication committee. 95% CI was calculated using Jeffrey's method. |
| Secondary | Percentage of Participants With a Favorable Per Participant Microbiological Response at EOT Visit-Micro-ITT Analysis Set | Up to 24 hours after the last infusion on Day 14 | Favorable microbiological response was defined as eradication or presumed eradication. Eradication was defined as absence (or urine quantification \<10\^3 colony forming units per milliliter \[CFU/mL\] for cUTI participants) of causative pathogen from an appropriately obtained specimen at the site of infection. Presumed eradication was defined as repeat culture of specimens were not performed/clinically indicated in a participant who had a clinical response of cure (specific to cIAI and HAP/VAP participants). |
| Secondary | Percentage of Participants With a Favorable Per Participant Microbiological Response at TOC Visit-Micro-ITT Analysis Set | Day 28 | Favorable microbiological response was defined as eradication or presumed eradication. Eradication was defined as absence (or urine quantification \<10\^3 colony forming units per milliliter \[CFU/mL\] for cUTI participants) of causative pathogen from an appropriately obtained specimen at the site of infection. Presumed eradication was defined as repeat culture of specimens were not performed/clinically indicated in a participant who had a clinical response of cure (specific to cIAI and HAP/VAP participants). |
| Secondary | Percentage of Participants With a Favorable Per Participant Microbiological Response at EOT Visit-ME Analysis Set | Up to 24 hours after the last infusion on Day 14 | Favorable microbiological response was defined as eradication or presumed eradication. Eradication was defined as absence (or urine quantification \<10\^3 CFU/mL for cUTI participants) of causative pathogen from an appropriately obtained specimen at the site of infection. Presumed eradication was defined as repeat culture of specimens were not performed/clinically indicated in a participant who had a clinical response of cure (specific to cIAI and HAP/VAP participants). |
| Secondary | Percentage of Participants With a Favorable Per Participant Microbiological Response at TOC Visit-ME Analysis Set | Day 28 | Favorable microbiological response was defined as eradication or presumed eradication. Eradication was defined as absence (or urine quantification \<10\^3 CFU/mL for cUTI participants) of causative pathogen from an appropriately obtained specimen at the site of infection. Presumed eradication was defined as repeat culture of specimens were not performed/clinically indicated in a participant who had a clinical response of cure (specific to cIAI and HAP/VAP participants). |
| Secondary | Percentage of Pathogens According to Favourable Per-Pathogen Microbiological Response at the EOT Visit-Micro-ITT Analysis Set | Up to 24 hours after the last infusion on Day 14 | Favorable microbiological response was defined as eradication or presumed eradication. Eradication was defined as absence (or urine quantification \<10\^3 CFU/mL for cUTI participants) of causative pathogen from an appropriately obtained specimen at the site of infection. Presumed eradication was defined as repeat culture of specimens were not performed/clinically indicated in a participant who had a clinical response of cure (specific to cIAI and HAP/VAP participants). |
| Secondary | Percentage of Pathogens According to Favourable Per-Pathogen Microbiological Response at the TOC Visit-Micro-ITT Analysis Set | Day 28 | Favorable microbiological response was defined as eradication or presumed eradication. Eradication was defined as absence (or urine quantification \<10\^3 CFU/mL for cUTI participants) of causative pathogen from an appropriately obtained specimen at the site of infection. Presumed eradication was defined as repeat culture of specimens were not performed/clinically indicated in a participant who had a clinical response of cure (specific to cIAI and HAP/VAP participants). |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Clinical Cure at the Test of Cure (TOC) Visit -Microbiological Intent to Treat (Micro-ITT) Analysis Set | Day 28 | Micro-ITT analysis set was a subset of the ITT analysis set and included all participants who had at least 1 MBL-positive Gram-negative baseline pathogen from an adequate specimen at the start of study treatment. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Clinical Cure at the TOC Visit-Microbiologically Evaluable (ME) Analysis Set | Day 28 | ME analysis set: Participants from micro-ITT who received at least 48 hours of study therapy or \<48 hours before discontinuation due to an adverse event, no concomitant antibiotics against baseline MBL positive pathogens between first dose of study therapy and TOC (excluding participants with failed study therapy requiring additional antibiotics), had baseline organisms confirmed by central microbiological testing (except when locally confirmed) and no indeterminate clinical outcomes at TOC. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Clinical Cure at the End of Treatment (EOT) Visit- Micro-ITT Analysis Set | Up to 24 hours after the last infusion on Day 14 | Micro-ITT analysis set was a subset of the ITT analysis set and included all participants who had at least 1 MBL-positive Gram-negative baseline pathogen from an adequate specimen at the start of study treatment. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Clinical Cure at the EOT Visit- ME Analysis Set | Up to 24 hours after the last infusion on Day 14 | ME analysis set: Participants from micro-ITT who received at least 48 hours of study therapy or \<48 hours before discontinuation due to an adverse event, no concomitant antibiotics against baseline MBL positive pathogens between first dose of study therapy and TOC (excluding participants with failed study therapy requiring additional antibiotics), had baseline organisms confirmed by central microbiological testing (except when locally confirmed) and no indeterminate clinical outcomes at TOC. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With a Favorable Per Participant Microbiological Response at EOT Visit-Micro-ITT Analysis Set | Up to 24 hours after the last infusion on Day 14 | Micro-ITT analysis set was a subset of the ITT analysis set and included all participants who had at least 1 MBL-positive Gram-negative baseline pathogen from an adequate specimen at the start of study treatment. Participants with a per participant response of Indeterminate were excluded from this analysis. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With a Favorable Per Participant Microbiological Response at TOC Visit-Micro-ITT Analysis Set | Day 28 | Micro-ITT analysis set was a subset of the ITT analysis set and included all participants who had at least 1 MBL-positive Gram-negative baseline pathogen from an adequate specimen at the start of study treatment. Participants with a per participant response of indeterminate were excluded from this analysis. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With a Favorable Per Participant Microbiological Response at EOT Visit-ME Analysis Set | Up to 24 hours after the last infusion on Day 14 | ME analysis set: Participants from micro-ITT who received at least 48 hours of study therapy or \<48 hours before discontinuation due to an adverse event; no concomitant antibiotics against baseline MBL positive pathogens between first dose of study therapy and TOC (excluding participants with failed study therapy requiring additional antibiotics), had baseline organisms confirmed by central microbiological testing (except when locally confirmed) and no indeterminate clinical outcomes at TOC. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With a Favorable Per Participant Microbiological Response at TOC Visit-ME Analysis Set | Day 28 | ME analysis set: Participants from micro-ITT who received at least 48 hours of study therapy or \<48 hours before discontinuation due to an adverse event, no concomitant antibiotics against baseline MBL positive pathogens between first dose of study therapy and TOC (excluding participants with failed study therapy requiring additional antibiotics), had baseline organisms confirmed by central microbiological testing (except when locally confirmed) and no indeterminate clinical outcomes at TOC. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Pathogens According to Favourable Per-Pathogen Microbiological Response at the EOT Visit-Micro-ITT Analysis Set | Up to 24 hours after the last infusion on Day 14 | Micro-ITT analysis set was a subset of the ITT analysis set and included all participants who had at least 1 MBL-positive Gram-negative baseline pathogen from an adequate specimen at the start of study treatment. All pathogens reported under 'Overall Number of Pathogens Analyzed' contributed data to the table; however, may not have evaluable data for every row. Here, 'Number Analyzed (n)'= pathogens evaluable for specified rows. | Percentage of pathogens | NUMBER |
| SECONDARY | Percentage of Pathogens According to Favourable Per-Pathogen Microbiological Response at the TOC Visit-Micro-ITT Analysis Set | Day 28 | Micro-ITT analysis set was a subset of the ITT analysis set and included all participants who had at least 1 MBL-positive Gram-negative baseline pathogen from an adequate specimen at the start of study treatment. All pathogens reported under 'Overall Number of Pathogens Analyzed' contributed data to the table; however, may not have evaluable data for every row. n= pathogens evaluable for specified rows. | Percentage of pathogens | NUMBER |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 outcomesResults by group212
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Clinical Cure at the Test of Cure (TOC) Visit -Microbiological Intent to Treat (Micro-ITT) Analysis Set | Aztreonam- Avibactam (ATM- AVI) | 41.7 | 95% Confidence Interval 18.0 to 68.8 | Percentage of participants | |
| Percentage of Participants With Clinical Cure at the Test of Cure (TOC) Visit -Microbiological Intent to Treat (Micro-ITT) Analysis Set | Best Available Therapy (BAT) | 0.0 | 95% Confidence Interval NA to NA | Percentage of participants | |
| Percentage of Participants With Clinical Cure at the TOC Visit-Microbiologically Evaluable (ME) Analysis Set | Aztreonam- Avibactam (ATM- AVI) | 55.6 | 95% Confidence Interval 25.4 to 82.7 | Percentage of participants | |
| Percentage of Participants With Clinical Cure at the TOC Visit-Microbiologically Evaluable (ME) Analysis Set | Best Available Therapy (BAT) | 0.0 | 95% Confidence Interval NA to NA | Percentage of participants | |
| Percentage of Participants With Clinical Cure at the End of Treatment (EOT) Visit- Micro-ITT Analysis Set | Aztreonam- Avibactam (ATM- AVI) | 58.3 | 95% Confidence Interval 31.2 to 82.0 | Percentage of participants | |
| Percentage of Participants With Clinical Cure at the End of Treatment (EOT) Visit- Micro-ITT Analysis Set | Best Available Therapy (BAT) | 0.0 | 95% Confidence Interval NA to NA | Percentage of participants | |
| Percentage of Participants With Clinical Cure at the EOT Visit- ME Analysis Set | Aztreonam- Avibactam (ATM- AVI) | 66.7 | 95% Confidence Interval 34.8 to 89.6 | Percentage of participants | |
| Percentage of Participants With Clinical Cure at the EOT Visit- ME Analysis Set | Best Available Therapy (BAT) | 0.0 | 95% Confidence Interval NA to NA | Percentage of participants | |
| Percentage of Participants With a Favorable Per Participant Microbiological Response at EOT Visit-Micro-ITT Analysis Set | Aztreonam- Avibactam (ATM- AVI) | 81.82 | Percentage of participants | ||
| Percentage of Participants With a Favorable Per Participant Microbiological Response at EOT Visit-Micro-ITT Analysis Set | Best Available Therapy (BAT) | 0.0 | Percentage of participants |
1 to 10 of 212Source ClinicalTrials.gov
See all 212 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Aztreonam- Avibactam (ATM- AVI) | 12 | |
| Overall Study | STARTED | Best Available Therapy (BAT) | 3 | |
| Overall Study | Treated | Aztreonam- Avibactam (ATM- AVI) | 12 | |
| Overall Study | Treated | Best Available Therapy (BAT) | 2 | |
| Overall Study | COMPLETED | Aztreonam- Avibactam (ATM- AVI) | 9 | |
| Overall Study | COMPLETED | Best Available Therapy (BAT) | 1 | |
| Overall Study | NOT COMPLETED | Aztreonam- Avibactam (ATM- AVI) | 3 | |
| Overall Study | NOT COMPLETED | Best Available Therapy (BAT) | 2 |
Source ClinicalTrials.gov
Adverse events76
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 | Thrombocytopenia | Blood and lymphatic system disorders | Aztreonam- Avibactam (ATM- AVI) | 1 | 12 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Best Available Therapy (BAT) | 0 | 2 | |
| other | Ocular hypertension | Eye disorders | Aztreonam- Avibactam (ATM- AVI) | 1 | 12 | |
| other | Ocular hypertension | Eye disorders | Best Available Therapy (BAT) | 0 | 2 | |
| other | Frequent bowel movements | Gastrointestinal disorders | Aztreonam- Avibactam (ATM- AVI) | 1 | 12 | |
| other | Frequent bowel movements | Gastrointestinal disorders | Best Available Therapy (BAT) | 0 | 2 | |
| other | Chest discomfort | General disorders | Aztreonam- Avibactam (ATM- AVI) | 1 | 12 | |
| other | Chest discomfort | General disorders | Best Available Therapy (BAT) | 0 | 2 | |
| other | Pyrexia | General disorders | Aztreonam- Avibactam (ATM- AVI) | 0 | 12 | |
| other | Pyrexia | General disorders | Best Available Therapy (BAT) | 1 | 2 |
1 to 10 of 76Source ClinicalTrials.gov
See all 76 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Aztreonam- Avibactam (ATM- AVI) | 2 | 12 |
| Total, all-cause mortality | Best Available Therapy (BAT) | 1 | 3 |
| Total, other adverse events | Aztreonam- Avibactam (ATM- AVI) | 9 | 12 |
| Total, other adverse events | Best Available Therapy (BAT) | 1 | 2 |
| Total, serious adverse events | Aztreonam- Avibactam (ATM- AVI) | 5 | 12 |
| Total, serious adverse events | Best Available Therapy (BAT) | 2 | 2 |
Source ClinicalTrials.gov
Papers3
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Aztreonam- Avibactam (ATM- AVI) vs Best Available Therapy (BAT): Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) | Trial comparisons |
| Aztreonam- Avibactam (ATM- AVI) vs Best Available Therapy (BAT): deaths from any cause | Trial comparisons |
| Aztreonam- Avibactam (ATM- AVI) vs Best Available Therapy (BAT): 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.
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