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.
Aperçu de l'étude
Statut
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Tanta, Egypte, 31527
- Tanta University
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La 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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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. |
|
Comparateur actif: 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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in Platelet Count
Délai: 3 months after treatment
|
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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Presence of Bleeding Manifestation
Délai: 3 months after treatment
|
Bleeding manifestations was assessed clinically and recorded according to their presence or absence. |
3 months after treatment
|
|
Change in Bleeding Severity Score
Délai: 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
|
|
Change in Regulatory T-Cell (T-reg) Percentage
Délai: 3 months after treatment
|
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
Délai: 3 months after treatment
|
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
Délai: 3 months after treatment
|
The percentage of CD25+ cells was measured by flow cytometry to explore immunological changes following treatment. |
3 months after treatment
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 36264MS488/1/24
Plan pour les données individuelles des participants (IPD)
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Description du régime IPD
The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Délai de partage IPD
After the end of study for one year.
Critères d'accès au partage IPD
The data will be available upon a reasonable request from the corresponding author.
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
Informations sur les médicaments et les dispositifs, documents d'étude
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