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Era of COVID-19 and the related panic lead to widely spread antibiotics misuse especially for azithromycin. Cross sensitivity between azithromycin and clarithromycin can impact success rates of H. pylori treatment regimens.(1) Here we aim to explore this point in Egyptian patients.
Sample size Supposing the cure rate of clarithromycin-based regimen to levofloxacin based regimen is 69% versus 84.5% respectively. Using Medcalc, the minimal required sample size is 116 patients for each arm (type 1 error= 5%, type II error=20%). Each arm increased by 10% to compensate for drop-out. The sample size will be 135 for each arm.
Study Arms:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Clarithromycin based |
|
| Group 2 | Experimental | Levofloxacin based |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amoxicillin | Drug | Anti-H. pylori regimens |
|
| Measure | Description | Time Frame |
|---|---|---|
| H. pylori eradication rates | 6 weeks from end of treatment and at least 2 weeks with no administration of PPIs |
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Inclusion Criteria:
Exclusion Criteria:
• Women who are pregnant or lactating, patients previously treated with H. pylori eradication therapy, those with recent exposure to antibiotics within the previous 3 months, patients who previously underwent gastric surgery, patients with malignant neoplasms, and patients with other severe concomitant diseases like renal, hepatic impairement, heart failure NYHA class II or more, hypoalbuminemia and those with possible clinically significant drug-drug interaction with any of the study's drugs will be excluded.
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| Name | Affiliation | Role |
|---|---|---|
| Ahmed Kamal | Alexandria University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alexandria University. | Alexandria | 21131 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36670359 | Derived | Kamal A, Ghazy RM, Sherief D, Ismail A, Ellakany WI. Helicobacter pylori eradication rates using clarithromycin and levofloxacin-based regimens in patients with previous COVID-19 treatment: a randomized clinical trial. BMC Infect Dis. 2023 Jan 20;23(1):36. doi: 10.1186/s12879-023-07993-8. |
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| ID | Term |
|---|---|
| D000658 | Amoxicillin |
| D017291 | Clarithromycin |
| D064704 | Levofloxacin |
| ID | Term |
|---|---|
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 |
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| Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D015242 | Ofloxacin |
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |