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Trial record 2 of 6 for:    "Thrombocytopenic Purpura, Autoimmune" | "Amoxicillin"

Effects of Helicobacter Pylori Eradication in Children With Chronic Immune Thrombocytopenic Purpura

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ClinicalTrials.gov Identifier: NCT03172676
Recruitment Status : Not yet recruiting
First Posted : June 1, 2017
Last Update Posted : February 1, 2018
Sponsor:
Information provided by (Responsible Party):
Mary Makram Kamel, Assiut University

Brief Summary:
Thrombocytopenia refers to a reduction in platelet count to (<150 × 109/L). Immune thrombocytopenic purpura is an acquired autoimmune disorder defined by isolated thrombocytopenia and the exclusion of other causes of thrombocytopenia

Condition or disease Intervention/treatment Phase
Immune Thrombocytopenia Drug: Amoxicillin 50 mg/kg/day in 2 divided doses for 14 days. Drug: Clarithromycin 15 mg/kg/day in 2 divided doses for 14 days. Drug: Proton pump inhibitor 1 mg/kg/day in 2 divided doses 1 month Phase 4

Detailed Description:
Helicobacter pylori was recently demonstrated as an etiological factor in immune thrombocytopenic purpura in some prospective studies, with reports of platelet numbers increasing in these patients after Helicobacter pylori eradication treatment.However, other studies have shown a negative result after eradication treatment of Helicobacter pylori infection in patients with chronic immune thrombocytopenic purpura, leading to controversy.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Helicobacter Pylori Eradication Therapy in Children With Chronic Immune Thrombocytopenic Purpura
Estimated Study Start Date : December 1, 2018
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : December 30, 2019


Arm Intervention/treatment
No Intervention: Helicobacter pylori negative patients
chronic immune thrombocytopenic purpura patients who will be diagnosed negative for Helicobacter pylori infection using detection of Helicobacter pylori antigen in stool of these patients.
Active Comparator: Helicobacter pylori positive patients with intervention
chronic immune thrombocytopenic purpura patients who will be diagnosed positive for Helicobacter pylori infection using detection of Helicobacter pylori antigen in stool of these patients will receive treatment of Helicobacter pylori: Amoxicillin for 14 days, Clarithromycin for 14 days and Proton pump inhibitor for one month).
Drug: Amoxicillin 50 mg/kg/day in 2 divided doses for 14 days.
chronic immune thrombocytopenic purpura patients who will be diagnosed positive for helicobacter pylori infection will receive Amoxicillin for 14 days.

Drug: Clarithromycin 15 mg/kg/day in 2 divided doses for 14 days.
chronic immune thrombocytopenic purpura patients who will be diagnosed positive for helicobacter pylori infection will receive Clarithromycin for 14 days.

Drug: Proton pump inhibitor 1 mg/kg/day in 2 divided doses 1 month
chronic immune thrombocytopenic purpura patients who will be diagnosed positive for helicobacter pylori infection will receive proton pump inhibitor for 1 month.

No Intervention: Helicobacter pylori positive patients without intervention
chronic immune thrombocytopenic purpura patients who will be diagnosed positive for Helicobacter pylori infection using detection of Helicobacter pylori antigen in stool of these patients will not receive treatment of Helicobacter pylori during the study,these patient group will receive treatment of Helicobacter pylori after the end of the study



Primary Outcome Measures :
  1. effects of Helicobacter pylori infection eradication on platelet counts of chronic immune thrombocytopenic patients [ Time Frame: 6 months ]
    platelet counts will be measured at the start of the study ,before the starting of the interventions, and after 6 months. platelet response will be classified as: 1-complete response: platelet count> 150 × 109/L , 2-partial response: platelet count : 50-150 × 109/L , no response: platelet count < 50 × 109/L.



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Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. chronic immune thrombocytopenic purpura patients who still have thrombocytopenia > 12 months
  2. age <18 years .
  3. diagnosis of immune thrombocytopenic purpura according to American Society of Hematology criteria based on an initial platelet count <100×103/μL .
  4. Patients diagnosed as steroid and immunoglobulin resistant chronic immune thrombocytopenic purpura .

exclusion criteria:

  1. Patients with acute immune thrombocytopenic purpura . .
  2. age >18 years.
  3. thrombocytopenia was related to autoimmune disorders, drugs, a family history consistent with inherited thrombocytopenia, human immunodeficiency virus infection, hepatitis.
  4. previous history of Helicobacter pylori eradication; and history of medication with proton pump inhibitors, H2- receptor antagonists, or antibiotics in the previous 4 weeks.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03172676


Contacts
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Contact: Fahim Mohamed, MD 00201002500073 fahim.osman@med.au.edu.eg
Contact: Mervat Amin, MD 00201142606221 mamuosif2002@gmail.com

Sponsors and Collaborators
Assiut University

Publications:
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Responsible Party: Mary Makram Kamel, principal investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03172676     History of Changes
Other Study ID Numbers: ITPHP
First Posted: June 1, 2017    Key Record Dates
Last Update Posted: February 1, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Amoxicillin
Thrombocytopenia
Purpura
Purpura, Thrombocytopenic
Purpura, Thrombocytopenic, Idiopathic
Blood Platelet Disorders
Hematologic Diseases
Blood Coagulation Disorders
Hemorrhage
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Thrombotic Microangiopathies
Immune System Diseases
Hemorrhagic Disorders
Autoimmune Diseases
Clarithromycin
Proton Pump Inhibitors
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors