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.
Studieöversikt
Status
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
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Tanta, Egypten, 31527
- Tanta University
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 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. |
|
Aktiv komparator: 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. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Change in Platelet Count
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Presence of Bleeding Manifestation
Tidsram: 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
Tidsram: 3 months after treatment
|
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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 36264MS488/1/24
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Tidsram för IPD-delning
After the end of study for one year.
Kriterier för IPD Sharing Access
The data will be available upon a reasonable request from the corresponding author.
IPD-delning som stöder informationstyp
- STUDY_PROTOCOL
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