ClinicalTrials.gov
ClinicalTrials.gov Menu

Levofloxacin in Preventing Infection in Young Patients With Acute Leukemia Receiving Chemotherapy or Undergoing Stem Cell Transplantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01371656
Recruitment Status : Completed
First Posted : June 13, 2011
Results First Posted : June 25, 2018
Last Update Posted : July 24, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single;   Primary Purpose: Supportive Care
Conditions: Acute Leukemias of Ambiguous Lineage
Bacterial Infection
Diarrhea
Fungal Infection
Musculoskeletal Complications
Neutropenia
Recurrent Childhood Acute Lymphoblastic Leukemia
Recurrent Childhood Acute Myeloid Leukemia
Secondary Acute Myeloid Leukemia
Untreated Childhood Acute Myeloid Leukemia and Other Myeloid Malignancies
Intervention: Drug: levofloxacin

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Arm I (Levofloxacin)

Patients receive levofloxacin PO or IV over 60-90 minutes once or twice daily beginning on day 3 during 2 consecutive courses of chemotherapy or beginning on day -2 during HSCT and continuing until blood counts recover.

levofloxacin: Given PO or IV

Arm II (Standard of Care) Patients receive established standard of care and receive chemotherapy or HSCT as patients in Arm I.

Participant Flow:   Overall Study
    Arm I (Levofloxacin)   Arm II (Standard of Care)
STARTED   314   310 
COMPLETED   250   296 
NOT COMPLETED   64   14 
Death                7                4 
Physician Decision                46                7 
Withdrawal by Subject                7                0 
Ineligible                4                3 



  Baseline Characteristics

Population Description
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.
No text entered.

Reporting Groups
  Description
Arm I (Levofloxacin)

Patients receive levofloxacin PO or IV over 60-90 minutes once or twice daily beginning on day 3 during 2 consecutive courses of chemotherapy or beginning on day -2 during HSCT and continuing until blood counts recover.

levofloxacin: Given PO or IV

Arm II (Standard of Care) Patients receive established standard of care and receive chemotherapy or HSCT as patients in Arm I.
Total Total of all reporting groups

Baseline Measures
   Arm I (Levofloxacin)   Arm II (Standard of Care)   Total 
Overall Participants Analyzed 
[Units: Participants]
 314   310   624 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      275  87.6%      284  91.6%      559  89.6% 
Between 18 and 65 years      39  12.4%      26   8.4%      65  10.4% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Median (Standard Deviation)
 9.44  (6.18)   9.18  (5.89)   9.31  (6.03) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      120  38.2%      127  41.0%      247  39.6% 
Male      194  61.8%      183  59.0%      377  60.4% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      89  28.3%      56  18.1%      145  23.2% 
Not Hispanic or Latino      208  66.2%      246  79.4%      454  72.8% 
Unknown or Not Reported      17   5.4%      8   2.6%      25   4.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      22   7.0%      17   5.5%      39   6.3% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      35  11.1%      45  14.5%      80  12.8% 
White      217  69.1%      216  69.7%      433  69.4% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      40  12.7%      32  10.3%      72  11.5% 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
United States   287   272   559 
Canada   26   36   62 
India   1   0   1 
Mexico   0   1   1 
Ireland   0   1   1 


  Outcome Measures

1.  Primary:   Comparison of the Percentage of Patients Having Bacteremia Incidence Between Levofloxacin vs. No Prophylaxis Arms   [ Time Frame: Up to 60 days after enrollment or receiving levofloxacin ]

2.  Secondary:   Comparison of the Percentage of Patients Having Antibiotic Exposures Between Arms   [ Time Frame: Up to 60 days after enrollment or receiving levofloxacin ]

3.  Secondary:   Comparison of the Percentage of Patients Having Incidence of Fever and Febrile Neutropenia Between Arms   [ Time Frame: Up to 60 days after enrollment or receiving levofloxacin ]

4.  Secondary:   Comparison of the Percentage of Patients Having Severe Infection Between Arms   [ Time Frame: Up to 60 days after enrollment or receiving levofloxacin ]

5.  Secondary:   Comparison of the Percentage of Patients That Died Due to Bacterial Infection Between Arms   [ Time Frame: Up to 60 days after enrollment or receiving levofloxacin ]

6.  Secondary:   Comparison of the Percentage of Patients Having Incidence of Musculoskeletal Adverse Events Including Tendinopathy (Tendonitis and Tendon Rupture) Between Arms   [ Time Frame: Enrollment, 2 months and 12 months post infection observation period ]

7.  Secondary:   Comparison of the Percentage of Patients Having Incidence of CDAD Between Arms   [ Time Frame: Up to 60 days after enrollment or receiving levofloxacin ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Results Reporting Coordinator
Organization: Children's Oncology Group
phone: 352-273-0567
e-mail: resultsreportingcoordinator@childrensoncologygroup.org



Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT01371656     History of Changes
Other Study ID Numbers: ACCL0934
NCI-2011-02636 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000695661 ( Other Identifier: ClinicalTrials.gov )
ACCL0934 ( Other Identifier: Children's Oncology Group )
COG-ACCL0934 ( Other Identifier: DCP )
ACCL0934 ( Other Identifier: CTEP )
U10CA095861 ( U.S. NIH Grant/Contract )
First Submitted: June 4, 2011
First Posted: June 13, 2011
Results First Submitted: May 25, 2018
Results First Posted: June 25, 2018
Last Update Posted: July 24, 2018