An interventional study of Prednisone + Azithromycin and Prednisone in Azithromycin, Corticosteroids and Children, sponsored by Tanta University. Completed at 1 site in Egypt. Open to participants aged Up to 12 Years. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by Tanta University · Not applicable, Interventional, and Treatment
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.
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.
503 studies on the registry are indexed under Purpura, Thrombocytopenic, Idiopathic; 158 are open to participants now.
This study's enrollment of 30 is below the median of 58 across 376 interventional studies indexed under Purpura, Thrombocytopenic, Idiopathic.
Browse Purpura, Thrombocytopenic, Idiopathic studies →Tanta University is the lead sponsor of 1,010 studies on the registry; 321 are open to participants now.
Of its 15 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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) alone
Drug: Prednisone
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.
Patients received oral prednisone (2 mg/kg/day, maximum 60 mg, for 5-7 days) alone.
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.
Time frame: 3 months after treatment
Presence of Bleeding Manifestation
Bleeding manifestations was assessed clinically and recorded according to their presence or absence.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 3 months after treatment
Plan to share: Yes — The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Supporting information: Study protocol
Time frame: After the end of study for one year.
Access criteria: The data will be available upon a reasonable request from the corresponding author.
No publications or documents are linked to this record.
Ran from Mar 2024 to primary completion in Feb 2025, 11 months.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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Purpura, Thrombocytopenic, Idiopathic →