Trial · NCT07890480
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | All-Cause Mortality at Day 30 | Within 30 days after treatment initiation | Proportion of participants who die from any cause within 30 days after initiation of aztreonam-avibactam (ATM-AVI) or ceftazidime-avibactam plus aztreonam (CZA-ATM), regardless of the cause of death. |
| Secondary | Favorable Clinical Response at Day 7 | Day 7 after treatment initiation | Proportion of participants with a favorable clinical response, defined as the absence of fever and hypotension, together with improvement in the signs and symptoms of the index infection. |
| Secondary | Clinical Cure at the End of Treatment | At completion of antimicrobial treatment for the index infection | Proportion of participants achieving clinical cure, defined as resolution of fever and hypotension for at least 72 hours, together with resolution of the signs and symptoms of the index infection. The end of treatment corresponds to completion of all antimicrobial treatment directed at the infectious episode. |
| Secondary | Microbiological Cure | From treatment initiation through the end of treatment | Proportion of evaluable participants with documented conversion of cultures from the index infection site to negative. Assessment will be based on follow-up cultures obtained as part of routine clinical care. |
| Secondary | All-Cause Mortality at Day 7 | Within 7 days after treatment initiation | Proportion of participants who die from any cause within 7 days after initiation of ATM-AVI or CZA-ATM treatment. |
| Secondary | Infection-Related Mortality at Day 7 | Within 7 days after treatment initiation | Proportion of participants who die within 7 days after treatment initiation in the presence of microbiological, histological, or clinical evidence of active infection, after excluding alternative causes of death. |
| Secondary | Infection-Related Mortality at Day 30 | Within 30 days after treatment initiation | Proportion of participants who die within 30 days after treatment initiation in the presence of microbiological, histological, or clinical evidence of active infection, after excluding alternative causes of death. |
| Secondary | Infection Relapse Within 60 Days | Within 60 days after treatment initiation | Proportion of participants experiencing recurrence of infection caused by the same microorganism responsible for the index infection within 60 days after initiation of ATM-AVI or CZA-ATM treatment. |
| Secondary | Incidence of Hematological Abnormalities | During treatment and up to 30 days after treatment completion | Proportion of participants developing hematological abnormalities, including leukopenia (leukocyte count below 4,000/mm³), neutropenia (neutrophil count below 1,000/mm³), eosinophilia (eosinophil count above 500/mm³), thrombocytopenia (platelet count below 150,000/mm³), or anemia according to institutional reference ranges. |
| Secondary | Incidence of Hepatic Toxicity | During treatment and up to 30 days after treatment completion | Proportion of participants developing hepatic toxicity, defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) above the upper limit of normal (ULN). Hepatitis is defined as transaminase elevation at least 5 times the ULN, or at least 3 times the ULN accompanied by symptoms such as abdominal pain, nausea, or vomiting. |
| Secondary | Incidence of Acute Kidney Injury | During treatment and up to 30 days after treatment completion | Proportion of participants developing acute kidney injury, defined as an increase in serum creatinine of at least 0.3 mg/dL or at least 1.5 times baseline, or urine output below 0.5 mL/kg/hour for at least 6 hours. |
| Secondary | Incidence of Allergic Reactions | During treatment and up to 30 days after treatment completion | Proportion of participants experiencing allergic reactions, including rash, angioedema, anaphylaxis, or severe cutaneous reactions such as erythema multiforme or toxic epidermal necrolysis. |
| Secondary | Incidence of Gastrointestinal Symptoms | During treatment and up to 30 days after treatment completion | Proportion of participants experiencing diarrhea and/or vomiting during the safety assessment period. |
| Secondary | Incidence of Neuropsychiatric Symptoms | During treatment and up to 30 days after treatment completion | Proportion of participants experiencing delirium, encephalopathy, or dysgeusia during the safety assessment period. |
| Secondary | Incidence of Clostridioides difficile Infection | During treatment and up to 30 days after treatment completion | Proportion of participants developing Clostridioides difficile infection, defined as at least 3 unformed stools within 24 hours without an alternative explanation, together with microbiological evidence of toxigenic C. difficile by toxin detection or molecular testing. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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