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Treatment of Preschool Children With Upper Respiratory Tract Illnesses Using Azythromycin and Lower Respiratory Tract Symptoms Using Oral Corticosteroids. (APRIL - OCELOT)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01272635
First Posted: January 10, 2011
Last Update Posted: December 28, 2016
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.
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
dave mauger, Milton S. Hershey Medical Center
Results First Submitted: March 11, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Asthma
Wheezing
Interventions: Drug: Azithromycin
Drug: Prednisolone
Other: Placebo Azithromycin
Drug: Placebo Prednisolone

  Participant Flow
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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
Azithromycin/Prednisolone

Active Azithromycin: Suspension, 12 mg/kg once daily for 5 days, maximum dose 500mg/day

Active Prednisolone: Syrup, 1 mg/kg/dose twice daily for 5 days, maximum dose 60mg/day

Azithromycin/Placebo

Active Azithromycin: Suspension, 12 mg/kg once daily for 5 days, maximum dose 500mg/day

Placebo Prednisolone: Syrup, 1 mg/kg/dose twice daily for 5 days, maximum dose 60mg/day

Placebo/Prednisolone

Placebo Azithromycin: Suspension, 12 mg/kg once daily for 5 days, maximum dose 500mg/day

Active Prednisolone: Syrup, 1 mg/kg/dose twice daily for 5 days, maximum dose 60mg/day

Placebo/Placebo

Placebo Azithromycin: Suspension, 12 mg/kg once daily for 5 days, maximum dose 500mg/day

Placebo Prednisolone: Syrup, 1 mg/kg/dose twice daily for 5 days, maximum dose 60mg/day


Participant Flow:   Overall Study
    Azithromycin/Prednisolone   Azithromycin/Placebo   Placebo/Prednisolone   Placebo/Placebo
STARTED   153   154   148   152 
COMPLETED   122   134   117   129 
NOT COMPLETED   31   20   31   23 
Lost to Follow-up                31                20                31                23 



  Baseline Characteristics
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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
Azythromycin Azithromycin: Suspension, 12 mg/kg once daily for 5 days, maximum dose 500mg/day
Placebo Placebo Azithromycin: Suspension, 12 mg/kg once daily for 5 days, maximum dose 500mg/day
Total Total of all reporting groups

Baseline Measures
   Azythromycin   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 307   300   607 
Age 
[Units: Months]
Mean (Standard Deviation)
 41.9  (16.5)   41.1  (16.4)   41.5  (16.5) 
Gender 
[Units: Participants]
Count of Participants
     
Female      124  40.4%      118  39.3%      242  39.9% 
Male      183  59.6%      182  60.7%      365  60.1% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      91  29.6%      92  30.7%      183  30.1% 
Not Hispanic or Latino      216  70.4%      208  69.3%      424  69.9% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      3   1.0%      5   1.7%      8   1.3% 
Asian      7   2.3%      3   1.0%      10   1.6% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      80  26.1%      77  25.7%      157  25.9% 
White      177  57.7%      185  61.7%      362  59.6% 
More than one race      40  13.0%      30  10.0%      70  11.5% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
     
United States   307   300   607 
Urgent care or ED visits in prior year 
[Units: Visits]
Mean (Standard Deviation)
 2.5  (1.7)   2.5  (1.6)   2.5  (1.6) 
Wheezing episodes in prior year 
[Units: Episodes]
Mean (Standard Deviation)
 4.5  (3.4)   4.4  (2.9)   4.5  (3.2) 
Hospitalizations for respiratory symptoms in prior year 
[Units: Hospitalizations]
Median (Inter-Quartile Range)
 1 
 (0 to 4) 
 1 
 (0 to 4) 
 1 
 (0 to 4) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Progression to Clinically Significant Lower Respiratory Tract Symptoms   [ Time Frame: 14 days after initiation of APRIL therapy ]

2.  Primary:   OCELOT: Pediatric Respiratory Assessment Measure   [ Time Frame: 36-72 hours after initiation of OCELOT therapy ]

3.  Secondary:   Asthma Related Symptoms Among RTI Progressing to Severe LRTI   [ Time Frame: 14 days after initiation of therapy ]

4.  Secondary:   Absence From School, Daycare, and/or Parental Work   [ Time Frame: 14 days after initiation of therapy ]

5.  Secondary:   Urgent Care Visits, ED Visits and Hospitalizations   [ Time Frame: 14 days after initiation of therapy ]

6.  Secondary:   Drug Related Side Effects   [ Time Frame: 14 days after initiation of therapy ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: David Mauger
Organization: Penn State University
phone: 717-531-7178
e-mail: dtm5@psu.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: dave mauger, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT01272635     History of Changes
Other Study ID Numbers: AsthmaNet 002
1U10HL098115 ( U.S. NIH Grant/Contract )
First Submitted: January 7, 2011
First Posted: January 10, 2011
Results First Submitted: March 11, 2016
Results First Posted: December 28, 2016
Last Update Posted: December 28, 2016