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Completed

NCT Number: NCT00945555

Observational Non-Interventional Study Of Febrile Neutropenia Patients To Evaluate Antibacterial Therapeutical Options

The purpose of this study was to define and classify antibacterial agents used in Turkey for patients with febrile neutropenia.

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Key information

Conditions

Febrile Neutropenia Agranulocytosis Cytopenia Hematologic Diseases Hemic and Lymphatic Diseases Leukocyte Disorders Leukopenia Neutropenia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pfizer Investigational Site, Kayseri, Turkey, Turkey (Türkiye)

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients who are 18 years old and above.
  • Patients who have undergone allogeneic/autologous or peripheral stem cell transplantation following induction or consolidation treatment due to acute hematological malignancy.
  • Patients who have a neutrophil count below 500 cells per cubic millimeter (cells/mm^3) or below 1000 cells/mm^3 with an expectancy to rapidly decrease below 500 cells/mm^3.
  • Patients with a body temperature more than or equal to (≥)38.3 degrees Celsius (101 degrees Fahrenheit) on single oral measurement or detected ≥38.0 degrees Celsius for at least an hour and thus started on antibacterial treatment will be included in the trial.

Exclusion criteria

  • Patients who are pregnant or considering pregnancy.

Treatment and study plan

Antibacterial agent for the treatment of febrile neutropenia

Drug

The antibacterial agent used by the investigators for febrile neutropenia will be determined and classified in the preference order

Primary outcomes

  1. Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring Febrile Neutropenia (FEN) in Their Therapeutical Approach: Empirical

    Time frame: Baseline

  2. Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring FEN in Their Therapeutical Approach: Targeted

    Time frame: Baseline

Secondary outcomes

  1. Mean Body Temperature

    Time frame: Baseline, Day 4, Day 7 on Average (till the End of Treatment)

  2. Mean Neutrophil Count

    Time frame: Baseline, Day 4, Day 7 on Average (till the End of Treatment)

  3. Percentage of Participants in Whom New Infection Was Determined on Day 4

    Time frame: Day 4

  4. Percentage of Participants in Whom New Infection Was Determined at End of Treatment

    Time frame: Day 7 on Average (till the End of Treatment)

  5. Percentage Survivors

    Time frame: Day 7 on Average (till the End of Treatment)

  6. Percentage of Participants Who Had a Treatment Modification

    Time frame: Day 4, Day 7 on Average (till the End of Treatment)

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

Multi-Center, Non-Interventional, Observational Study To Evaluate The Antibacterial Therapeutical Options In Febrile Neutropenia Patients

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jul 24, 2009
Registry last updated
Apr 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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