Trial reportClinical and translational science2021
A randomized, double-blind, placebo- and positive-controlled crossover study of the effects of durlobactam on cardiac repolarization in healthy subjects.
Trial report in Clinical and translational science, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
8 citing papers in PubMed, 1 synthesis or guideline pooled it, 12 citations in OpenAlex.
- Effects of Nacubactam and Its Metabolites on QTc Interval: A Pooled Analysis of Two Randomized Phase 1 Studies.Clinical and translational science · 2026Pooled it
- Population pharmacokinetic analyses for sulbactam-durlobactam using Phase 1, 2, and 3 data.Antimicrobial agents and chemotherapy · 2025Trial
- Clinical efficacy, safety and pharmacokinetics of novel β-lactam/β-lactamase inhibitor combinations: a systematic review.JAC-antimicrobial resistance · 2025Review
- Innovative Antibiotic Therapies for Carbapenem-Resistant Gram-Negative Bacterial Infections: Clinical Efficacy, Safety, and Comparative Studies.Microorganisms · 2025Review
- Sulbactam-durlobactam: a β-lactam/β-lactamase inhibitor combination targetingFuture microbiology · 2024Review
- Sulbactam/Durlobactam: First Approval.Drugs · 2023Review
- Pathogen-Targeted Clinical Development to Address Unmet Medical Need: Design, Safety, and Efficacy of the ATTACK Trial.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2023Article
- Durlobactam in the Treatment of Multidrug-ResistantJournal of clinical medicine · 2022Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 3 institutions in 2 countries.
Funding
Abstract
Durlobactam (formerly ETX2514) is a diazabicyclooctane β-lactamase inhibitor that inhibits class A, C, and D β-lactamases. Sulbactam combined with durlobactam has in vitro and in vivo activity against Acinetobacter baumannii including carbapenem- and colistin-resistant isolates and is being developed for treating serious infections due to A. baumannii. The effect of a single supratherapeutic dose of durlobactam on the heart rate corrected QT interval (QTc) was evaluated in healthy subjects in a placebo- and active-controlled, single-infusion, three-way crossover study. Subjects were randomized to 1 of 6 sequences that included a single 3-h i.v. infusion of durlobactam 4 g (supratherapeutic dose), a single 3-h i.v. infusion of placebo, and a single 3-h i.v. infusion of placebo plus a single oral dose of moxifloxacin 400 mg given open-label at the end of the i.v. infusion. In each treatment period, Holter electrocardiogram (ECG) measurements were obtained from predose through 24 h post-start of infusion. For the primary ECG end point, placebo-corrected change-from-baseline corrected QT Fridericia's formula (ΔΔQTcF), no significant change was observed with durlobactam. A concentration-QT analysis demonstrated no significant effect of durlobactam on ECG parameters, including QT interval prolongation. Thus, durlobactam has a low risk for prolonging the QT interval and is unlikely to produce any proarrhythmic effects.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.