EU Clinical Trial Information System (CTIS)

Brand Logo

Brand Logo Light

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

I searched for some studies on AstraZeneca Clinical Trials, and found these studies that may also be of interest to you.
Here is the link to my search results

Official Title

Participants will receive a single intravenous (IV) dose of MEDI4893 5000 milligrams (mg) on Day 1 of the study.

Participants will receive a single IV dose of placebo matched to MEDI4893 on Day 1 of the study.

Participants will receive a single IV dose of MEDI4893 2000 mg on Day 1 of the study.

Clinical trial looking at safety and efficacy of MEDI4893 in prevention of pneumonia caused by Staphylococcus aureus in high-risk patients

Study of the Efficacy and Safety of MEDI4893

NCT ID

Patient Level Data

Therapeutic Area

Participants will receive a single IV dose of MEDI4893 2000 or 5000 mg on Day 1 of the study.

CD-ID-MEDI4893-1139 Protocol amendment 5_redacted_FINAL_APPROVED

CD-ID-MEDI4893-1139 Statistical Analysis Plan_Final v4.0_Redacted_FINAL_APPROVED

Research Site

A Phase 2 Randomised, Double-blind, Placebo-controlled, Single-dose, Dose-ranging Study of the Efficacy and Safety of MEDI4893, a Human Monoclonal Antibody Against Staphylococcus aureus Alpha Toxin in Mechanically Ventilated Adult Subjects.

The EAC S aureus pneumonia was based on clinical, radiographic, and microbiologic criteria. Clinical criteria: 1 major criteria (PaO2/FiO2 ratio < 240 mmHg maintained for at least 4 hours or decrease in PaO2/FiO2 by >= 50 mmHg maintained for at least 4 hrs or a need to initiate noninvasive mechanical ventilation or re-initiate invasive mechanical ventilation because of respiratory failure or worsening of respiratory status); and at least 2 of minor criteria (systemic signs of infection, production of purulent sputum/endotracheal secretions, new onset of cough, physical examination findings consistent with pneumonia/pulmonary consolidation, dyspnea, and/or tachypnea). Radiographic criteria: new or worsening infiltrate consistent with pneumonia on chest X-ray obtained within 24 hrs of event. Microbiologic criteria: at least 1 culture positive for S aureus (respiratory specimen, or blood, or pleural fluid aspirate or lung tissue culture during episode of pneumonia).

An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.

An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.

A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.

An AESI is one of scientific and medical interest specific to understanding of the study drug and may have required close monitoring and rapid communication by the investigator to the sponsor. An AESI may have been serious or non-serious.

An NOCD defined as a newly diagnosed medical condition that is of a chronic, ongoing nature. It is observed after receiving the study drug and is assessed by the investigator as medically significant.

Age Continuous

Sex: Female, Male

Race (NIH/OMB)

Ethnicity (NIH/OMB)

Modified Intent-to-treat (mITT) population included all participants, who received any dose of study drug
and analyzed according to their randomized treatment group.

The EAC S aureus pneumonia was based on clinical, radiographic, and microbiologic criteria. Clinical criteria: 1 major criteria (PaO2/FiO2 ratio < 240 mmHg maintained for at least 4 hours or decrease in PaO2/FiO2 by >= 50 mmHg maintained for at least 4 hrs or a need to initiate non-invasive mechanical ventilation or re-initiate invasive mechanical ventilation because of respiratory failure or worsening of respiratory status); and at least 2 of minor criteria (systemic signs of infection, production of purulent sputum/endotracheal secretions, new onset of cough, physical examination findings consistent with pneumonia/pulmonary consolidation, dyspnea, and/or tachypnea). Radiographic criteria: new or worsening infiltrate consistent with pneumonia on chest X-ray obtained within 24 hrs of event. Microbiologic criteria: at least 1 culture positive for S aureus (respiratory specimen, or blood, or pleural fluid aspirate or lung tissue culture during episode of pneumonia).

The key efficacy analyses were based
on 5000 mg MEDI4893 and placebo.
Participants who received 2000 mg
MEDI4893 were summarized
descriptively.

An mITT population included all participants, who received any dose of study drug and analyzed according to their randomized treatment group.

Percentage of Participants With Endpoint Adjudication Committee-Determined (EAC) Staphylococcus aureus (S aureus) Pneumonia

As-treated population included all participants, who received any dose of study drug and analyzed according to the treatment they actually received.

Number of Participants With Treatment Emergent Adverse Events (TEAEs) Through 31 Days

Number of Participants With TEAEs Through 91 Days

Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs)

Number of Participants With Adverse Events of Special Interest (AESIs)

Number of Participants With New Onset Chronic Diseases (NOCDs)

Maximum observed serum concentration (Cmax) of MEDI4893 is reported.

An Intent-to-treat (ITT) population included all randomized participants and were analyzed according to their randomized treatment group. Participants who had quantifiable pharmacokinetic (PK) samples were analyzed for this outcome measure.

Maximum Observed Serum Concentration (Cmax) of MEDI4893

Area under the serum concentration time curve from time zero to last measurable concentration (AUC[0 - Last]) of MEDI4893 is reported.

An ITT population included all randomized participants and were analyzed according to their randomized treatment group. Participants who had quantifiable PK samples were analyzed for this outcome measure.

Area Under the Serum Concentration Time Curve From Time Zero to Last Measurable Concentration (AUC [0-Last]) of MEDI4893

Observed serum concentration of MEDI4893 through 30 days post dose (C30) is reported. Serum concentration of MEDI4893 through 30 days post dose accounted the overall concentration of MEDI4893 measured on specified time points (Days 1, 4, 8, 15, 22, and 30).

Observed Serum Concentration of MEDI4893 through 30 Days Post Dose (C30)

Observed serum concentration of MEDI4893 through 90 days post dose (C90) is reported. Serum concentration of MEDI4893 through 90 days post dose accounted the overall concentration of MEDI4893 measured on specified time points (Days 1, 4, 8, 15, 22, 31, 61, and 91).

Observed Serum Concentration of MEDI4893 through 90 Days Post Dose (C90)

Positive at baseline

Positive post-baseline

Positive at baseline and post-baseline

Not detected at baseline; positive post-baseline

Positive at baseline; not detected post-baseline

Participants with ADA-positive at any of Day 31, Day 61, or Day 91 post-baseline assessments were always counted as "positive" at post-baseline.

Number of Participants With Positive Anti-Drug Antibodies (ADA) Titer to MEDI4893

Overall Study

A total of 767 participants consented to participate in the study, of which 554 were screen failures. A total of 213 participants were randomized in the study.

Arms	Assigned Interventions
Active Comparator: MEDI4893 5000 mg Participants will receive a single intravenous (IV) dose of MEDI4893 5000 milligrams (mg) on Day 1 of the study.	Drug: MEDI4893 Participants will receive a single IV dose of MEDI4893 2000 or 5000 mg on Day 1 of the study.
Placebo Comparator: Placebo Participants will receive a single IV dose of placebo matched to MEDI4893 on Day 1 of the study.	Other: Placebo Participants will receive a single IV dose of placebo matched to MEDI4893 on Day 1 of the study.
Active Comparator: MEDI4893 2000 mg Participants will receive a single IV dose of MEDI4893 2000 mg on Day 1 of the study.	Drug: MEDI4893 Participants will receive a single IV dose of MEDI4893 2000 or 5000 mg on Day 1 of the study.

Study of the Efficacy and Safety of MEDI4893 - SAATELLITE

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Documents available

CD-ID-MEDI4893-1139 Protocol amendment 5_redacted_FINAL_APPROVED

CD-ID-MEDI4893-1139 Statistical Analysis Plan_Final v4.0_Redacted_FINAL_APPROVED

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator