Trial · NCT01969799

Aerosolized Amikacin and Fosfomycin in Mechanically Ventilated Patients With Gram-negative Pneumonia

NCT01969799, Phase 2, Completed, Cardeas Pharma; results first posted 2017-07-02

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Aerosolized Amikacin and Fosfomycin in Mechanically Ventilated Patients With Gram-negative Pneumonia. Trials, record NCT01969799. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01969799

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Aerosolized Amikacin and Fosfomycin in Mechanically Ventilated Patients With Gram-negative Pneumonia
NCT number: NCT01969799
Status: Completed
Phases: Phase 2
Enrollment: 143 participants, actual
Lead sponsor: Cardeas Pharma
Conditions: Pneumonia, Bacterial
Interventions: Amikacin fosfomycin inhalation solution, Aerosolized placebo
First posted: 2013-10-25
Last updated: 2017-07-02
Other registries' IDs: eudract:2013-002855-13
Results first posted: 2017-07-02

Source ClinicalTrials.gov

Registered outcomes8

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline in Clinical Pulmonary Infection Score (CPIS) For Each Patient, Value Obtained From a Daily Assessment Over the 10 Day Study Period Was Compared to Baseline, and the LSM Data Represent the Change From Baseline Data Over All Days .	10 day treatment period.	Change from baseline in Clinical Pulmonary Infection Score (CPIS) For each patient, value obtained from a daily assessment over the 10 day study period was compared to baseline, and the LSM data represent the change from baseline data over all days. Daily CPIS will be determined by one blinded, central reviewer in order to minimize inter-observer variability. The scale ranges from 0 to 13, with 13 being the worst. The value of zero would be a healthy patient with no evidence of pneumonia. For each patient, there was a daily assessment for the 10 day study period.
Secondary	Composite Endpoint of Mortality and Clinical Cure	Day 1 - Day 28	The hierarchical composite endpoint of mortality, then clinical cure (defined as both absence of Gram-negative bacteria and CPIS at Day 14 \< 6). The tables reflect a winner of matched pairs, ties are not noted.
Secondary	Composite Endpoint of Mortality and Ventilator-free Days	Day 1- Day 28	The hierarchical composite endpoint of mortality, then ventilator-free days. The table reflects winners of matched pairs, ties are not noted.
Secondary	Number of Days Free of Mechanical Ventilation From Day 1 Through Day 28	Day 1 - Day 28	Number of days free of mechanical ventilation from Day 1 through Day 28 mean days.
Secondary	Number of ICU Days From Day 1 Through Day 28	Day 1 - Day 28
Secondary	Microbiological Response Rates in Patients Positive for Multi-drug Resistant Gram-negative Bacteria	Day 14	Microbiological response rates at Day 14 in patients whose pre-study treatment bronchoalveolar lavage (BAL) was positive for multi-drug resistant Gram-negative bacteria. Response is defined as not have a positive tracheal aspirate culture on Day 14
Secondary	Mortality From Day 1 Through Day 28	Day 1 - Day 28	Mortality from Day 1 through Day 28, all causes, does not reflect just infection only
Secondary	Clinical Relapse Rate	Day 11 - Day 28	Clinical relapse rates (defined as a new episode of pneumonia requiring reinstitution of IV antibiotics) from Day 11 through Day 28

Source ClinicalTrials.gov

Outcomes8

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline in Clinical Pulmonary Infection Score (CPIS) For Each Patient, Value Obtained From a Daily Assessment Over the 10 Day Study Period Was Compared to Baseline, and the LSM Data Represent the Change From Baseline Data Over All Days .	10 day treatment period.	MITT	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Composite Endpoint of Mortality and Clinical Cure	Day 1 - Day 28	MITT	participants	NUMBER
SECONDARY	Composite Endpoint of Mortality and Ventilator-free Days	Day 1- Day 28	MITT	participants	NUMBER
SECONDARY	Number of Days Free of Mechanical Ventilation From Day 1 Through Day 28	Day 1 - Day 28	MITT	Days ± SD	MEAN
SECONDARY	Number of ICU Days From Day 1 Through Day 28	Day 1 - Day 28	MITT	Days	MEAN
SECONDARY	Microbiological Response Rates in Patients Positive for Multi-drug Resistant Gram-negative Bacteria	Day 14	patients with MDR bacteria at baseline BAL	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Mortality From Day 1 Through Day 28	Day 1 - Day 28	MITT	participants	NUMBER
SECONDARY	Clinical Relapse Rate	Day 11 - Day 28	MITT	participants	NUMBER

Source ClinicalTrials.gov

Results by group20

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Change From Baseline in Clinical Pulmonary Infection Score (CPIS) For Each Patient, Value Obtained From a Daily Assessment Over the 10 Day Study Period Was Compared to Baseline, and the LSM Data Represent the Change From Baseline Data Over All Days .	Amikacin Fosfomycin Inhalation Solution		-0.76	Standard Error 0.403	units on a scale
Change From Baseline in Clinical Pulmonary Infection Score (CPIS) For Each Patient, Value Obtained From a Daily Assessment Over the 10 Day Study Period Was Compared to Baseline, and the LSM Data Represent the Change From Baseline Data Over All Days .	Aerosolized Placebo		-0.88	Standard Error 0.391	units on a scale
Composite Endpoint of Mortality and Clinical Cure	Amikacin Fosfomycin Inhalation Solution	Mortality first	10		participants
Composite Endpoint of Mortality and Clinical Cure	Aerosolized Placebo	Mortality first	10		participants
Composite Endpoint of Mortality and Clinical Cure	Amikacin Fosfomycin Inhalation Solution	Clinical Cure first	15		participants
Composite Endpoint of Mortality and Clinical Cure	Aerosolized Placebo	Clinical Cure first	18		participants
Composite Endpoint of Mortality and Ventilator-free Days	Amikacin Fosfomycin Inhalation Solution	Mortality first	10		participants
Composite Endpoint of Mortality and Ventilator-free Days	Aerosolized Placebo	Mortality first	10		participants
Composite Endpoint of Mortality and Ventilator-free Days	Amikacin Fosfomycin Inhalation Solution	Ventilator free days	13		participants
Composite Endpoint of Mortality and Ventilator-free Days	Aerosolized Placebo	Ventilator free days	27		participants

1 to 10 of 20Source ClinicalTrials.gov

See all 20 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Amikacin Fosfomycin Inhalation Solution	71
Overall Study	STARTED	Aerosolized Placebo	72
Overall Study	COMPLETED	Amikacin Fosfomycin Inhalation Solution	54
Overall Study	COMPLETED	Aerosolized Placebo	58
Overall Study	NOT COMPLETED	Amikacin Fosfomycin Inhalation Solution	17
Overall Study	NOT COMPLETED	Aerosolized Placebo	14

Source ClinicalTrials.gov

Adverse events94

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	Hyopokalaemia	Metabolism and nutrition disorders	Amikacin Fosfomycin Inhalation Solution	6	71	6
other	Hyopokalaemia	Metabolism and nutrition disorders	Aerosolized Placebo	6	72	8
other	Septic shock	Infections and infestations	Amikacin Fosfomycin Inhalation Solution	4	71	4
other	Septic shock	Infections and infestations	Aerosolized Placebo	7	72	7
other	Pneumonia	Infections and infestations	Amikacin Fosfomycin Inhalation Solution	5	71	5
other	Pneumonia	Infections and infestations	Aerosolized Placebo	5	72	5
other	Sepsis	Infections and infestations	Amikacin Fosfomycin Inhalation Solution	5	71	5
other	Sepsis	Infections and infestations	Aerosolized Placebo	4	72	4
other	Pleural effusion	Respiratory, thoracic and mediastinal disorders	Amikacin Fosfomycin Inhalation Solution	4	71	5
other	Pleural effusion	Respiratory, thoracic and mediastinal disorders	Aerosolized Placebo	5	72	6

1 to 10 of 94Source ClinicalTrials.gov

See all 94 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Amikacin Fosfomycin Inhalation Solution
Total, all-cause mortality	Aerosolized Placebo
Total, other adverse events	Amikacin Fosfomycin Inhalation Solution	54	71
Total, other adverse events	Aerosolized Placebo	58	72
Total, serious adverse events	Amikacin Fosfomycin Inhalation Solution	28	71
Total, serious adverse events	Aerosolized Placebo	27	72

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
27890714	DERIVED

Source PubMed

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 comparisons4

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Amikacin Fosfomycin Inhalation Solution vs Aerosolized Placebo: Microbiological Response Rates in Patients Positive for Multi-drug Resistant Gram-negative Bacteria	Trial comparisons
Amikacin Fosfomycin Inhalation Solution vs Aerosolized Placebo: Mortality From Day 1 Through Day 28	Trial comparisons
Amikacin Fosfomycin Inhalation Solution vs Aerosolized Placebo: Clinical Relapse Rate	Trial comparisons
Amikacin Fosfomycin Inhalation Solution vs Aerosolized Placebo: 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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT01969799

GET https://conductscience.org/api/trials/v1/NCT01969799/events?page=2

API reference For AI assistants