Oritavancin for Bacterial Infections in Children

Phase 1

Recruiting

Research Sponsored by Melinta Therapeutics, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Males and females <18 years of age

Suspected or diagnosed Gram positive bacterial infection for which the subject is receiving standard antibiotic therapy; or peri-operative prophylactic use of antibiotics

Must not have

Females who are of childbearing potential and unwilling to practice abstinence or use at least two methods of contraception or female patients of childbearing who are lactating or have a positive pregnancy test result at screening

Males who are unwilling to practice abstinence or use an acceptable method of birth control during the entire study period

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 336 hours post infusion start time for cohorts 1-4 and 168 hours for cohort 5

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug to see if it is safe and effective in children with a bacterial infection.

Who is the study for?

This trial is for children under 18 with suspected or confirmed Gram-positive bacterial infections. Neonates must be at least 34 weeks post-conception age. Participants need IV access and will stay in the hospital for observation after receiving the drug. Those with septic shock, hypersensitivity to similar drugs, recent use of certain antibiotics, or females who are pregnant/lactating or not using contraception are excluded.

What is being tested?

The study tests Oritavancin's effects on pediatric patients with bacterial infections. It aims to understand how the body processes this drug (pharmacokinetics), its safety, and tolerability when given to kids and teenagers as either a treatment for infection or as a preventive measure during surgery.

What are the potential side effects?

While specific side effects in children aren't detailed here, Oritavancin may cause symptoms like allergic reactions, gastrointestinal issues (nausea/vomiting), skin reactions at injection site, liver enzyme changes, blood clotting problems and possibly others similar to adults.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am under 18 years old.

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I am currently being treated with antibiotics for a suspected or confirmed Gram positive bacterial infection.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am a woman able to have children and will use two forms of birth control or abstain.

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I agree to use birth control or practice abstinence during the study.

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I haven't taken certain antibiotics recently and don't plan to take them soon.

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I haven't used any experimental drugs or devices recently.

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I am currently experiencing severe infection or sudden blood pressure drops.

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I do not have any major organ system diseases.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 336 hours post infusion start time for cohorts 1-4 and 168 hours for cohort 5

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~336 hours post infusion start time for cohorts 1-4 and 168 hours for cohort 5

This trial's timeline: 3 weeks for screening, Varies for treatment, and 336 hours post infusion start time for cohorts 1-4 and 168 hours for cohort 5 for reporting.