Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Aerosolized Amikacin and Fosfomycin in Mechanically Ventilated Patients With Gram-negative Pneumonia
NCT01969799 · View on ClinicalTrials.gov ↗
Study Summary
To demonstrate the safety and efficacy of adjunctive therapy with the Amikacin fosfomycin inhalation system (AFIS) versus aerosolized placebo to treat Gram-negative pneumonia in mechanically ventilated patients receiving IV antibiotics.
Conditions Studied
Interventions
- DRUG Amikacin fosfomycin inhalation solution
- DRUG Aerosolized placebo
Study Locations (20)
Massachusetts
- — Boston
- — Burlington
- — Springfield
Florida
- — Gainesville
- — Jacksonville
Kentucky
- — Hazard
- — Lexington
Texas
- — El Paso
- — Houston
California
- — Los Angeles
Illinois
- — Chicago
Michigan
- — Detroit
Missouri
- — St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 143 participants |
| Start Date | 2013-12 |
| Est. Completion | 2016-04 |
| Phase | Phase 2 |
Interested in This Trial?
Always speak with your doctor before enrolling in a clinical trial.
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01969799
The ClinicalTrials.gov registry entry for NCT01969799 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 143 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cardeas Pharma, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Pneumonia, Bacterial appearing as the primary indexed condition, and to 2 interventions — of which Amikacin fosfomycin inhalation solution is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01969799 reports 20 study locations spanning 15 distinct geographic areas — top geographies include Massachusetts, Florida, Kentucky. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT01969799 about?
NCT01969799 is a clinical study titled "Aerosolized Amikacin and Fosfomycin in Mechanically Ventilated Patients With Gram-negative Pneumonia". To demonstrate the safety and efficacy of adjunctive therapy with the Amikacin fosfomycin inhalation system (AFIS) versus aerosolized placebo to treat Gram-negative pneumonia in mechanically ventilated patients receiving IV antibiotics.
What is the current status of trial NCT01969799?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 143 participants. The study started on 2013-12. Estimated completion is 2016-04.
What conditions does trial NCT01969799 study?
This clinical trial studies the following conditions: Pneumonia, Bacterial. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01969799?
The interventions under investigation include: Amikacin fosfomycin inhalation solution (DRUG), Aerosolized placebo (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01969799?
This trial is sponsored by Cardeas Pharma, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT01969799 being conducted?
This trial has 20 study locations across California, Florida, Illinois, Kentucky, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How Clinical Trials Work
Understand phases 1-4, trial design, randomization, and the informed consent process.
Patient Rights in Clinical Trials
Your rights as a participant: consent, withdrawal, privacy, and who to contact.
Finding the Right Clinical Trial
A practical guide to searching trials, understanding eligibility, and evaluating options.
All Guides
Browse our complete library of clinical trial educational resources.
Read our methodology — how this data is sourced, computed, and verified.