ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 5 of 15 for:    "Job syndrome" OR "Job's Syndrome"

Effect of Ranitidine on Hyper-IgE Recurrent Infection (Job's) Syndrome

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: NCT00527878
Recruitment Status : Terminated (Failure to enroll adequate patient numbers due to small number of eligible patients)
First Posted : September 11, 2007
Results First Posted : February 4, 2013
Last Update Posted : February 4, 2013
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions JOB's Syndrome
Hyper-IgE Recurrent Infection Syndrome
Immune Deficiency
Interventions Drug: Ranitidine
Drug: Placebo
Enrollment 16
Recruitment Details  
Pre-assignment Details 16 participants were screened but only 14 participants were randomized. Two individuals decided not to participate.
Arm/Group Title Placebo/Ranitidine Ranitidine/Placebo
Hide Arm/Group Description Ranitidine will be dosed orally at 150 mg twice daily for adults, and at 2-4 mg/kg/dose twice daily for children with a maximum dose of 150 mg twice daily. Liquid formulations will be provided for individuals unable to swallow pills. Subjects will be randomized to receive placebo for 12 months followed by 12 months of the ranitidine. Ranitidine will be dosed orally at 150 mg twice daily for adults, and at 2-4 mg/kg/dose twice daily for children with a maximum dose of 150 mg twice daily. Liquid formulations will be provided for individuals unable to swallow pills. Subjects will be randomized to receive ranitidine for 12 months followed by 12 months of the ranitidine.
Period Title: Intervention 1
Started 7 7
Completed 5 4
Not Completed 2 3
Period Title: Intervention 2
Started 5 4
Completed 5 4
Not Completed 0 0
Arm/Group Title Patients
Hide Arm/Group Description [Not Specified]
Overall Number of Baseline Participants 16
Hide Baseline Analysis Population Description
All participants whether or not they were randomized.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
<=18 years
6
  37.5%
Between 18 and 65 years
10
  62.5%
>=65 years
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 16 participants
25.2  (13.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
Female
8
  50.0%
Male
8
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 16 participants
16
1.Primary Outcome
Title Number of Infections in Subjects With HIES.
Hide Description Patients received one year of treatment medication and one year of placebo. New infections (bacterial, fungal, viral or parasitic) were defined as those requiring an addition or change of an antimicrobial (including topical, oral or intravenous therapies) or those requiring a medical procedure (i.e., incision and drainage of a skin abscess, warm soaks to aid abscess drainage or sinus drainage).
Time Frame 1 year on intervention
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients that completed both arms of the study (24 months)
Arm/Group Title Placebo Ranitidine
Hide Arm/Group Description:
Crossover study in which patients received one year of placebo and one year of ranitidine. This analysis will include the placebo for both arms.
Crossover study in which patients received one year of placebo and one year of ranitidine. This analysis will include the treatment for both arms.
Overall Number of Participants Analyzed 9 9
Median (Full Range)
Unit of Measure: infections
4
(2 to 25)
4
(0 to 15)
2.Secondary Outcome
Title New Skin Infections
Hide Description Patients reported the number of new skin infections
Time Frame 12 months placebo/12 months ranitidine
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients that completed the study
Arm/Group Title Placebo Ranitidine
Hide Arm/Group Description:
Crossover study in which patients received one year of placebo and one year of ranitidine. This analysis will include the placebo for both arms.
Crossover study in which patients received one year of placebo and one year of ranitidine. This analysis will include the treatment for both arms.
Overall Number of Participants Analyzed 9 9
Median (Full Range)
Unit of Measure: skin infections
1
(0 to 14)
0
(0 to 10)
3.Secondary Outcome
Title New Lung Infections
Hide Description Number of new infection while on placebo or study drug
Time Frame 12 months placebo and 12 months ranitidine
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients who completed the study
Arm/Group Title Placebo Ranitidine
Hide Arm/Group Description:
Crossover study in which patients received one year of placebo and one year of ranitidine. This analysis will include the placebo for both arms.
Crossover study in which patients received one year of placebo and one year of ranitidine. This analysis will include the treatment for both arms.
Overall Number of Participants Analyzed 9 9
Median (Full Range)
Unit of Measure: new lung infections
1
(0 to 4)
0
(0 to 4)
4.Secondary Outcome
Title Clinical Severity Score
Hide Description Scoring that was completed every 3 months. Clinical severity scored had outcomes that could range from 0 to 121 with 0 being the least severe and 121 being the most severe.
Time Frame one year on ranitidine and one year on placebo
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients who completed the study
Arm/Group Title Placebo Ranitidine
Hide Arm/Group Description:
Crossover study in which patients received one year of placebo and one year of ranitidine. This analysis will include the placebo for both arms.
Crossover study in which patients received one year of placebo and one year of ranitidine. This analysis will include the treatment for both arms.
Overall Number of Participants Analyzed 9 9
Mean (Full Range)
Unit of Measure: score on a scale
9.8
(3.2 to 27.5)
8.5
(3.5 to 30.3)
Time Frame [Not Specified]
Adverse Event Reporting Description Adverse events were not analyzed for each participant as 7 participants did not complete the study and so we were not able to evaluate for adverse events for both placebo and study medication.
 
Arm/Group Title Placebo Ranitidine
Hide Arm/Group Description this was a crossover study and patients received both placebo and study drug (ranitidine), both of which for 12 months, unless they terminated the study. This was a crossover study and patients received 12 months of ranitidine and 12 months of placebo, unless they terminated the study.
All-Cause Mortality
Placebo Ranitidine
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Ranitidine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/11 (36.36%)      4/12 (33.33%)    
Cardiac disorders     
hypotension [1]  1/11 (9.09%)  0/12 (0.00%) 
Infections and infestations     
pneumonia [2]  1/11 (9.09%)  0/12 (0.00%) 
pneumonia [3]  0/11 (0.00%)  1/12 (8.33%) 
skin abscess [2]  1/11 (9.09%)  0/12 (0.00%) 
groin abscess [2]  0/11 (0.00%)  1/12 (8.33%) 
central line infection [4]  1/11 (9.09%)  0/12 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
asthma [5]  0/11 (0.00%)  1 1/12 (8.33%) 
death from respiratory failure [6]  0/11 (0.00%)  1/12 (8.33%) 
[1]
Not thought to be related to study
[2]
Thought to be related to underlying disease
[3]
Thought to be related to underlying study
[4]
Not thought to be related to study medication
[5]
Not thought to be related
[6]
patient with death presumed to be related to narcotics.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo Ranitidine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/11 (90.91%)      11/12 (91.67%)    
Blood and lymphatic system disorders     
anemia  3/11 (27.27%)  1/12 (8.33%) 
neutropenia  3/11 (27.27%)  4/12 (33.33%) 
Eye disorders     
eyelid stye  1/11 (9.09%)  1/12 (8.33%) 
Gastrointestinal disorders     
gastric ulcer  1/11 (9.09%)  0/12 (0.00%) 
vomiting  1/11 (9.09%)  2/12 (16.67%) 
nausea  2/11 (18.18%)  1/12 (8.33%) 
abdominal pain  1/11 (9.09%)  1/12 (8.33%) 
occult blood in stool  1/11 (9.09%)  0/12 (0.00%) 
General disorders     
Dental problems  1/11 (9.09%)  1/12 (8.33%) 
pain  0/11 (0.00%)  1/12 (8.33%) 
tongue ulcer  1/11 (9.09%)  0/12 (0.00%) 
Hepatobiliary disorders     
elevated alkaline phosphatase  2/11 (18.18%)  0/12 (0.00%) 
elevated Liver function tests  1/11 (9.09%)  1/12 (8.33%) 
Immune system disorders     
pruritus  1/11 (9.09%)  2/12 (16.67%) 
Infections and infestations     
sinusitis  4/11 (36.36%)  6/12 (50.00%) 
otitis  4/11 (36.36%)  4/12 (33.33%) 
upper respiratory tract infection  4/11 (36.36%)  5/12 (41.67%) 
abscess  4/11 (36.36%)  5/12 (41.67%) 
Streptococcal sore throat  0/11 (0.00%)  1/12 (8.33%) 
candidiasis  2/11 (18.18%)  2/12 (16.67%) 
fever  2/11 (18.18%)  1/12 (8.33%) 
pneumonia  2/11 (18.18%)  0/12 (0.00%) 
infection  1/11 (9.09%)  0/12 (0.00%) 
urinary tract infection  0/11 (0.00%)  1/12 (8.33%) 
Musculoskeletal and connective tissue disorders     
fracture  0/11 (0.00%)  1/12 (8.33%) 
arthralgias  0/11 (0.00%)  1/12 (8.33%) 
Respiratory, thoracic and mediastinal disorders     
cough  3/11 (27.27%)  2/12 (16.67%) 
chest pain  0/11 (0.00%)  1/12 (8.33%) 
dyspnea  1/11 (9.09%)  0/12 (0.00%) 
Skin and subcutaneous tissue disorders     
rash  2/11 (18.18%)  3/12 (25.00%) 
folliculitis  0/11 (0.00%)  1/12 (8.33%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Alexandra Freeman MD, Staff Clinician, Lead Associate Investigator for Protocol
Organization: NIAID, NIH
Phone: 301-594-9045
Responsible Party: Steven M. Holland, M.D./National Institute of Allergy and Infectious Diseases, National Institutes of Health
ClinicalTrials.gov Identifier: NCT00527878     History of Changes
Other Study ID Numbers: 070218
07-I-0218
First Submitted: September 8, 2007
First Posted: September 11, 2007
Results First Submitted: February 1, 2013
Results First Posted: February 4, 2013
Last Update Posted: February 4, 2013