NCT03523221 Use of Dexamethasone in Prevention of the Second Phase or a Biphasic Reaction of Anaphylaxis
| NCT ID | NCT03523221 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Hamad Medical Corporation |
| Condition | Anaphylaxis |
| Study Type | INTERVENTIONAL |
| Enrollment | 210 participants |
| Start Date | 2018-04-15 |
| Primary Completion | 2024-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 210 participants in total. It began in 2018-04-15 with a primary completion date of 2024-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Anaphylaxis is an acute serious allergic reaction, with multi-organ system manifestations caused by the release of chemical mediators and it is potentially fatal . Between 5% and 14% of patients may experience a recurrence of anaphylaxis 8-12 hours after the initial presentation, called biphasic (late-phase) . The mainstay of treatment for children experiencing anaphylaxis remains adrenaline and H1-antihistamines. Corticosteroids are not life-saving and do not have an immediate effect on the symptoms of anaphylaxis but may help reduce or prevent a biphasic "late phase" reaction . The aim of this study is to compare the efficacy of oral glucocorticoids in prevention of the second phase or biphasic reaction of anaphylaxis, as compared to placebo in children, presenting to the pediatric emergency department (PEC Al-Sadd) with mild to moderate anaphylaxis (Prospective Study). Patients will be randomized to either one of the two treatment: Treatment 1: Dexamethasone 0.6mg/kg oral. Treatment 2 : Placebo All patients will be urgently treated for anaphylaxis according to guideline protocol. Enrolled patients will be given one of the study medications orally, and he /she will observe in the observation room with cardiac monitor and close monitoring by nurse. The treating physician will discharge patient when he/she looks well, breathing comfortably, has oxygen saturation \>94%, stable blood pressure and no gastrointestinal or neurological manifestation. Discharge patients will be sent home on anti-histamine (cetirizine) for 5days. All patients will be followed up for one week post discharge by a phone call asking about the general condition, relapse of symptoms, or need for readmission.
Eligibility Criteria
Inclusion Criteria: * All patients 3 monthes-14years presenting to the Pediatric Emergency Department (AlSadd) with mild to moderate anaphylaxis Exclusion Criteria: Patients with severe anaphylaxis. Patient with history of immunological diseases. Patients on steroids therapy Patient with moderate-severe asthma on medication Patients with severe asthma
Contact & Investigator
Khalid Al ansari, FRCP
PRINCIPAL INVESTIGATOR
Hamad Medical Corporation
Frequently Asked Questions
Who can join the NCT03523221 clinical trial?
This trial is open to participants of all sexes, aged 3 Months or older, up to 14 Years, studying Anaphylaxis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03523221 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT03523221 currently recruiting?
Yes, NCT03523221 is actively recruiting participants. Contact the research team at ralsayyed@hamad.qa for enrollment information.
Where is the NCT03523221 trial being conducted?
This trial is being conducted at Doha, Qatar.
Who is sponsoring the NCT03523221 clinical trial?
NCT03523221 is sponsored by Hamad Medical Corporation. The principal investigator is Khalid Al ansari, FRCP at Hamad Medical Corporation. The trial plans to enroll 210 participants.