Eligibility, any sex, with Legionnaires' Disease or Legionella Pneumophila Infections. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants With Treatment-Related Adverse EventsPrimary· 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)
Treatment-Related Adverse Event
Group
Value
95% CI
Zithromac Intravenous Use (Azithromycin Hydrate)
2
Treatment-Related Serious Adverse Event
Group
Value
95% CI
Zithromac Intravenous Use (Azithromycin Hydrate)
0
Clinical Effectiveness Rate in ParticipantsSecondary· 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.
Group
Value
95% CI
Zithromac Intravenous Use (Azithromycin Hydrate)
95.2
76.18 – 99.88
Adverse events — posted to ClinicalTrials.gov
Reporting threshold: 1.0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
To collect retrospectively the efficacy and safety information of azithromycin IV on patients with Legionnaires' disease related to their appropriate use in daily practice.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Pfizer
Last refreshed: 30 November 2017
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01784770.