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.
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Tanta, Egypte, 31527
- Tanta University
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 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. |
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. |
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Actieve vergelijker: Prednisone group
Patients received oral prednisone (2 mg/kg/day, maximum 60 mg, for 5-7 days) alone |
Patients received oral prednisone (2 mg/kg/day, maximum 60 mg, for 5-7 days) alone. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Change in Platelet Count
Tijdsspanne: 3 months after treatment
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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
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Presence of Bleeding Manifestation
Tijdsspanne: 3 months after treatment
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Bleeding manifestations was assessed clinically and recorded according to their presence or absence. |
3 months after treatment
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Change in Bleeding Severity Score
Tijdsspanne: 3 months after treatment
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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
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Change in Regulatory T-Cell (T-reg) Percentage
Tijdsspanne: 3 months after treatment
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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
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Change in CD4+ T-Cell Percentage
Tijdsspanne: 3 months after treatment
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The percentage of CD4+ T cells was measured by flow cytometry to explore changes in T-cell populations following treatment. |
3 months after treatment
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Change in CD25+ Cell Percentage
Tijdsspanne: 3 months after treatment
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The percentage of CD25+ cells was measured by flow cytometry to explore immunological changes following treatment. |
3 months after treatment
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Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 36264MS488/1/24
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
IPD-tijdsbestek voor delen
After the end of study for one year.
IPD-toegangscriteria voor delen
The data will be available upon a reasonable request from the corresponding author.
IPD delen Ondersteunend informatietype
- LEERPROTOCOOL
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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