CompletedNCT07928895ClinicalTrials.gov record

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

Azithromycin · Corticosteroids · Children · Newly Diagnosed Immune Thrombocytopenia

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THE QUICK READ

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type: Interventional
Phase: Not applicable
Age range: Not specified - 12 years
Sex eligible: All sexes
Healthy volunteers: Not accepted
Participants: 30 Actual

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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.

Read the full 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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

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.

Understand screening

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment: Random assignment
Masking: No masking

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

Prednisone group

Patients received oral prednisone (2 mg/kg/day, maximum 60 mg, for 5-7 days) alone

Drug: Prednisone

Prednisone + Azithromycin DRUG

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.

Prednisone DRUG

Patients received oral prednisone (2 mg/kg/day, maximum 60 mg, for 5-7 days) alone.

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