# Comparative effectiveness and complications of intravenous ceftriaxone compared with oral doxycycline in Lyme meningitis

> **NIH NIH R01** · RHODE ISLAND HOSPITAL · 2021 · $137,898

## Abstract

PROJECT SUMMARY
With more than 300,000 new cases of Lyme disease each year in the U.S., approximately half of new cases
occur in children. Children with Lyme meningitis, a clinical manifestation of Lyme disease, present with
headache, fever and fatigue. Previously, an intravenous antibiotic (ceftriaxone) was the recommended first
treatment for Lyme meningitis, but it is associated with a high rate of complications related either to the long-
term intravenous catheter placed for medication delivery or to complications from the medicine itself. Based on
European trials conducted in adults and small observational pediatric studies, some clinicians have begun
treating Lyme meningitis in children with an oral antibiotic (doxycycline), avoiding the complications associated
with intravenous ceftriaxone and reducing health care costs.
Our first goal is to compare oral doxycycline to intravenous ceftriaxone for the treatment of Lyme meningitis,
with a focus on both short-term recovery and long-term quality of life. Our second goal is to examine patient,
parent and clinician preferences to inform shared decision-making about Lyme meningitis treatments.
To accomplish our goals, we propose a comprehensive pediatric Lyme meningitis study, enrolling children at
20 U.S. centers located in regions of the U.S. where Lyme disease is endemic. Treatment decisions will be
made by the child’s doctors, per usual practice, and we will obtain informed consent to follow the outcomes
over the following six months. We will enroll a total of 210 children with Lyme meningitis to determine whether
oral doxycycline is not inferior to intravenous ceftriaxone for the treatment of Lyme meningitis in children. We
will interview patients, parents and clinicians to gain a nuanced understanding of the factors that shape
treatment decisions. The overall impact of this study will be to inform the best practices for the treatment of
children with Lyme meningitis accounting for the preferences of key stake holders.

## Key facts

- **NIH application ID:** 10210893
- **Project number:** 1R01AI151180-01A1
- **Recipient organization:** RHODE ISLAND HOSPITAL
- **Principal Investigator:** Aris C Garro
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $137,898
- **Award type:** 1
- **Project period:** 2021-09-01 → 2021-11-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10210893

## Citation

> US National Institutes of Health, RePORTER application 10210893, Comparative effectiveness and complications of intravenous ceftriaxone compared with oral doxycycline in Lyme meningitis (1R01AI151180-01A1). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10210893. Licensed CC0.

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