NCT07344506 CURE-H. Pylori: A Trial on the Combination of Anti-Ulcerants and Levofloxacin-Based Therapy for Helicobacter Pylori Eradication
| NCT ID | NCT07344506 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Dow University of Health Sciences |
| Condition | H. Pylori Gastrointestinal Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 942 participants |
| Start Date | 2025-05-01 |
| Primary Completion | 2026-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 942 participants in total. It began in 2025-05-01 with a primary completion date of 2026-05-01.
⚠ 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
This study, titled CURE-H. Pylori, is a three-arm, parallel-group, open-label, randomized controlled trial designed to evaluate the effectiveness of Dexlansoprazole, Lansoprazole, and Vonoprazan in combination with Levofloxacin and Amoxicillin for Helicobacter pylori eradication. H. pylori infection is a significant health issue worldwide, with an estimated prevalence of 44% globally and around 60% in Pakistan, leading to gastritis, peptic ulcer disease, and increased risks of gastric cancer and mucosa-associated lymphoid tissue lymphoma. Despite the widespread use of PPI-based triple therapies, treatment efficacy has decreased due to increasing antibiotic resistance, especially to Clarithromycin and Metronidazole. This study aims to assess the eradication rate of H. pylori in patients receiving either Dexlansoprazole 60mg, Lansoprazole 30mg, or Vonoprazan 20mg, each combined with Levofloxacin 500mg and Amoxicillin 1g for 14 days. Participants will be randomized into three arms (314 participants per arm) and assessed for H. pylori eradication using a Urea Breath Test (UBT) at follow-up, which will serve as the primary endpoint. Secondary objectives include assessing symptom improvement using the Gastrointestinal Symptom Rating Scale (GSRS), measuring symptoms such as reflux, abdominal pain, indigestion, diarrhea, and constipation. The study will enroll adult patients diagnosed with H. pylori via UBT and who are not currently receiving treatment for the infection. The study will be conducted at healthcare centers in major cities across Pakistan, including Peshawar, Faisalabad, Rawalpindi, Multan, Lahore, Karachi, and Quetta, over a 12-month period. All participants will sign informed consent forms before enrollment, ensuring they understand the study's procedures and risks. Statistical analysis will be performed using SPSS version 26, with categorical variables analyzed using the Chi-square or Fisher's exact test and continuous variables using descriptive statistics. The primary outcome is the H. pylori eradication rate, and secondary outcomes include the improvement in gastrointestinal symptoms. This study is significant because it aims to compare three different PPI-based therapies in the context of H. pylori eradication in a high-resistance population, providing much-needed data for tailoring treatment strategies in regions with high antibiotic resistance like Pakistan. The results could enhance the effectiveness and cost-efficiency of treatment regimens for H. pylori, ultimately improving patient outcomes and reducing the burden of gastric diseases. Ethical approval has been obtained from the Institutional Review Board (IRB) of Dow University of Health Sciences, Karachi, and all procedures will adhere to the principles of human subjects protection. This study will provide valuable insights into the comparative efficacy of different proton pump inhibitors when combined with Levofloxacin-based triple therapy, potentially leading to more effective treatment options for H. pylori infections in Pakistan and similar regions. The total required sample size for this study is 942 participants, with a 20% expected dropout rate. Data collection will be conducted at baseline and six weeks post-treatment, with the aim of addressing the region-specific challenges in H. pylori treatment and contributing to the global knowledge on optimal therapeutic strategies for this infection. Additionally, the trial's findings may contribute to the broader understanding of how regional antibiotic resistance patterns affect treatment outcomes and help shape future guidelines for H. pylori management in endemic areas. This trial will also help assess the safety and tolerability of the different therapies, providing a comprehensive evaluation of both therapeutic efficacy and patient quality of life post-treatment.
Eligibility Criteria
Inclusion Criteria: Adult patients of both sexes, presenting to the out-patient departments of the participating healthcare centres, and diagnosed through a UBT to have H.Pylori infection by their physician will be eligible for enrolment in the study, but are currently not receiving any treatment for H.Pylori infection. Exclusion Criteria: 1. Those who will not provide written consent for the study. 2. Patients with severe mental disability, 3. pregnant or lactating women, 4. those who are already on treatment for H.Pylori infection, and 5. those who have received any antibiotic within the last two weeks of enrolling in this study will be excluded. 6. Patients with known previous documented drug allergies for the current regime will be excluded from the trial
Frequently Asked Questions
Who can join the NCT07344506 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying H. Pylori Gastrointestinal Disease. 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 NCT07344506 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07344506 currently recruiting?
Yes, NCT07344506 is actively recruiting participants. Visit ClinicalTrials.gov or contact Dow University of Health Sciences to inquire about joining.
Where is the NCT07344506 trial being conducted?
This trial is being conducted at Karachi, Pakistan.
Who is sponsoring the NCT07344506 clinical trial?
NCT07344506 is sponsored by Dow University of Health Sciences. The trial plans to enroll 942 participants.