Azithromycin as an Adjunct to Corticosteroids in Children With Newly Diagnosed Immune Thrombocytopenia

Azithromycin as an Adjunct to Corticosteroids in Children With Newly Diagnosed Immune Thrombocytopenia: A Pilot Randomized Controlled Trial With Exploratory Analysis of Regulatory T Cells

This study aimed to evaluate the possible immunomodulatory effect of Azithromycin as an adjuvant treatment on the clinical and laboratory outcomes of children with newly diagnosed ITP through its effect on T-reg cells.

Study Overview

• Status: Completed
• Conditions: Children; Corticosteroids; Azithromycin; Newly Diagnosed Immune Thrombocytopenia
• Intervention / Treatment: Drug: Prednisone + Azithromycin; Drug: Prednisone

Detailed Description

Immune thrombocytopenia (ITP) is an autoimmune disorder characterized by a low platelet count (< 100 × 109/L) due to enhanced platelet clearance and compromised production, typically manifesting with bleeding.

Azithromycin (AZM), is abroad spectrum macrolide antibiotic with bacteriostatic properties, it also appears to has anti-inflammatory and immunomodulatory properties that are impartial of its antibacterial properties.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Tanta, Egypt, 31527
    • Tanta University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Eligible participants were children aged below 12 years.
• Patients with newly diagnosed immune thrombocytopenia (ITP) (within 3 months of onset) who were planned to receive corticosteroids as first-line therapy.

Exclusion Criteria:

• Patients had any other cytopenia, another autoimmune disease (e.g., systemic lupus erythematosus, screened by antinuclear antibody and anti-dsDNA).
• Secondary or suspected inherited thrombocytopenia.
• Congenital anomalies.
• Positive family history of thrombocytopenia, or concurrent severe infection.
• Children who did not respond to first-line therapy and required an additional treatment line.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Prednisone + Azithromycin group; Patients received oral prednisone (2 mg/kg/day, maximum 60 mg, for 5-7 days) plus Azithromycin (AZM) (10 mg/kg/day for 3 days.	Drug: Prednisone + Azithromycin; Patients received oral prednisone (2 mg/kg/day, maximum 60 mg, for 5-7 days) plus Azithromycin (AZM) (10 mg/kg/day for 3 days.
Active Comparator: Prednisone group; Patients received oral prednisone (2 mg/kg/day, maximum 60 mg, for 5-7 days) alone	Drug: Prednisone; Patients received oral prednisone (2 mg/kg/day, maximum 60 mg, for 5-7 days) alone.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Platelet Count	Platelet count was measured using a complete blood count to evaluate the hematological response to treatment. Platelet counts was compared between the prednisone plus azithromycin group and the prednisone-alone group at each follow-up assessment.	3 months after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of Bleeding Manifestation	Bleeding manifestations was assessed clinically and recorded according to their presence or absence.	3 months after treatment
Change in Bleeding Severity Score	Bleeding severity was assessed using the modified Buchanan and Adix bleeding score, which grades bleeding severity from grade 0 (no bleeding) to grade 5 (life-threatening bleeding).	3 months after treatment
Change in Regulatory T-Cell (T-reg) Percentage	Regulatory T-cell percentage was assessed using flow cytometry. T-reg cells is identified as CD4⁺CD25^high cells, and the percentage was compared between baseline and post-treatment measurements.	3 months after treatment
Change in CD4+ T-Cell Percentage	The percentage of CD4+ T cells was measured by flow cytometry to explore changes in T-cell populations following treatment.	3 months after treatment
Change in CD25+ Cell Percentage	The percentage of CD25+ cells was measured by flow cytometry to explore immunological changes following treatment.	3 months after treatment

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2024
• Primary Completion (Actual): February 28, 2025
• Study Completion (Actual): February 28, 2025

Study Registration Dates

• First Submitted: November 4, 2026
• First Submitted That Met QC Criteria: November 4, 2026
• First Posted (Actual): November 10, 2026

Study Record Updates

• Last Update Posted (Actual): November 10, 2026
• Last Update Submitted That Met QC Criteria: November 4, 2026
• Last Verified: November 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Organic Chemicals; Polycyclic Compounds; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Macrolides; Lactones; Pregnadienediols; Erythromycin; Polyketides; Prednisone; Azithromycin
• Other Study ID Numbers: 36264MS488/1/24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

IPD Sharing Time Frame

After the end of study for one year.

IPD Sharing Access Criteria

The data will be available upon a reasonable request from the corresponding author.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No