Trial · NCT01784770
Special Investigation Of Azithromycin IV For Legionnaires' Disease (Regulatory Post Marketing Commitment Plan)
NCT01784770, Completed, Pfizer; results first posted 2017-11-30
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Special Investigation Of Azithromycin IV For Legionnaires' Disease (Regulatory Post Marketing Commitment Plan). Trials, record NCT01784770. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01784770
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Special Investigation Of Azithromycin IV For Legionnaires' Disease (Regulatory Post Marketing Commitment Plan)
- NCT number
- NCT01784770
- Status
- Completed
- Enrollment
- 21 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Legionnaires' Disease, Legionella Pneumophila Infections
- Interventions
- Azithromycin IV
- First posted
- 2013-02-06
- Last updated
- 2017-11-30
- Results first posted
- 2017-11-30
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment-Related Adverse Events | 29 days | A treatment-related adverse event was any untoward medical occurrence attributed to Zithromac Intravenous use (and Zithromac Tablets) in a participant who received Zithromac Intravenous use. A treatment-related serious adverse event was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; lifethreatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Relatedness to Zithromac Intravenous use (and Zithromac Tablets) was assessed by the physician. |
| Secondary | Clinical Effectiveness Rate in Participants | 29 days | Clinical effectiveness rate in participants, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of asssable effectiveness analysis population, was presented along with the corresponding 2-sided 95% CI. Clinical effectiveness of Zithromac Intravenous use (and Zithromac Tablets) was determined by the physician based on clinical symptoms and laboratory findings, and assessed according to the following categories: (1) effective, (2) ineffective, or (3) unassessable. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment-Related Adverse Events | 29 days | The safety analysis set comprised of participants who satisfied the inclusion criteria and received Zithromac Intravenous use at least once. | Participants | NUMBER |
| SECONDARY | Clinical Effectiveness Rate in Participants | 29 days | The effectiveness analysis set comprised of participants in the safety analysis set who had effectiveness evaluation (overall evaluation by the physician based upon change in clinical symptoms and laboratory findings) at least once. Participants evaluated as unassessable were excluded from the calculation. | Percentage of Participants | NUMBER |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Treatment-Related Adverse Events | Zithromac Intravenous Use (Azithromycin Hydrate) | Treatment-Related Adverse Event | 2 | Participants | |
| Number of Participants With Treatment-Related Adverse Events | Zithromac Intravenous Use (Azithromycin Hydrate) | Treatment-Related Serious Adverse Event | 0 | Participants | |
| Clinical Effectiveness Rate in Participants | Zithromac Intravenous Use (Azithromycin Hydrate) | 95.2 | 95% Confidence Interval 76.18 to 99.88 | Percentage of Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Zithromac Intravenous Use (Azithromycin Hydrate) | 21 | |
| Overall Study | COMPLETED | Zithromac Intravenous Use (Azithromycin Hydrate) | 21 | |
| Overall Study | NOT COMPLETED | Zithromac Intravenous Use (Azithromycin Hydrate) | 0 |
Source ClinicalTrials.gov
Adverse events8
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 | Bradycardia | Cardiac disorders | Zithromac Intravenous Use (Azithromycin Hydrate) | 1 | 21 | |
| other | Hepatic function abnormal | Hepatobiliary disorders | Zithromac Intravenous Use (Azithromycin Hydrate) | 1 | 21 | |
| other | Liver disorder | Hepatobiliary disorders | Zithromac Intravenous Use (Azithromycin Hydrate) | 1 | 21 | |
| other | Toxic skin eruption | Skin and subcutaneous tissue disorders | Zithromac Intravenous Use (Azithromycin Hydrate) | 1 | 21 | |
| other | Chondrocalcinosis pyrophosphate | Musculoskeletal and connective tissue disorders | Zithromac Intravenous Use (Azithromycin Hydrate) | 1 | 21 | |
| other | Crystalluria | Renal and urinary disorders | Zithromac Intravenous Use (Azithromycin Hydrate) | 1 | 21 | |
| other | Pollakiuria | Renal and urinary disorders | Zithromac Intravenous Use (Azithromycin Hydrate) | 1 | 21 | |
| serious | Gastrointestinal haemorrhage | Gastrointestinal disorders | Zithromac Intravenous Use (Azithromycin Hydrate) | 1 | 21 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Zithromac Intravenous Use (Azithromycin Hydrate) | ||
| Total, other adverse events | Zithromac Intravenous Use (Azithromycin Hydrate) | 7 | 21 |
| Total, serious adverse events | Zithromac Intravenous Use (Azithromycin Hydrate) | 1 | 21 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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.
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/NCT01784770
GET https://conductscience.org/api/trials/v1/NCT01784770/registered