NCT06358209

Brief Summary

Ventriculitis is a severe infectious disease of the central nervous system with diverse etiologies. Currently, the treatment for ventriculitis is challenging, with poor prognosis. The mortality rate of ventriculitis is generally reported to be higher than 30%, with the highest reaching over 75%. Even among survivors, over 60% suffer from a variety of neurological sequelae, including cognitive impairment, gait disturbances, paralysis, behavioral disorders, and epilepsy. Currently, treatments for ventriculitis recommended by guidelines primarily focus on the selection and administration of antibiotics, while the effects of surgical interventions have not been fully elucidated. In recent years, several studies have explored the use of ventricular irrigation in ventriculitis, indicating that ventricular irrigation techniques may accelerate the control of ventricular infection, mitigate damage to the central nervous system caused by infections, improve the prognosis of ventriculitis, and reduce complications such as hydrocephalus. However, current studies are still relatively scarce, and mostly case reports and retrospective studies. High-quality evidence is still lacking for the application of ventricular irrigation in ventriculitis. This multicenter randomized controlled trial aims to explore the safety and effectiveness of ventricular irrigation compared to conventional treatment for ventriculitis, analyze the effectiveness of ventricular irrigation across different pathogen subgroups, and investigate independent risk factors for different prognostic states in patients with ventriculitis.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
310

participants targeted

Target at P75+ for not_applicable

Timeline
31mo left

Started Jul 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

35 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress27%
Jul 2025Dec 2028

First Submitted

Initial submission to the registry

March 31, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 10, 2024

Completed
1.2 years until next milestone

Study Start

First participant enrolled

July 1, 2025

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2028

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

February 25, 2026

Status Verified

February 1, 2026

Enrollment Period

3 years

First QC Date

March 31, 2024

Last Update Submit

February 23, 2026

Conditions

Central Nervous System Infections

Keywords

VentriculitisVentricular irrigation

Outcome Measures

Primary Outcomes (1)

  • Clinical cure rate

    Clinical cure rate at 4 weeks after enrollment and randomization

    4 weeks after enrollment

Secondary Outcomes (6)

  • GOSE

    up 6 months after enrollment and randomization

  • Microbial clearance rate

    4 weeks after enrollment

  • CSF test results

    At 8th day after enrollment, and within 1 week before discharge

  • Cranial CT or MRI indicating

    At 8th day after enrollment, and within 1 week before discharge

  • Length of ICU stay and hospital stay

    up to 6 months after enrollment and randomization

  • +1 more secondary outcomes

Study Arms (2)

Control group

NO INTERVENTION

Conventional treatments for ventriculitis, including: external ventricular drainage or lumbar cistern drainage for continuous drainage, systemic and intrathecal antibiotics along with other supportive care. The treatment plan, including the type, dosage, and duration of antibiotics, follows guidelines "2017 Infectious Diseases Society of America's Clinical Practice Guidelines for Healthcare-Associated Ventriculitis and Meningitis" and "Chinese Expert Consensus on Diagnosis and Treatment of Central Nervous System Infections in Neurosurgery (2021 Edition)".

Ventricular irrigation group

EXPERIMENTAL

Intervention group employs catheter ventricular irrigation with various forms. Lavage is performed with each time at least 200ml of normal saline, and irrigation treatment over 7 days. Additional treatments, including the administration of antibiotics, are consistent with those in the control group.

Procedure: Ventricular irrigation

Interventions

Ventricular irrigationPROCEDURE

Catheter ventricular irrigation can be employed by various forms. Lavage is performed with with each time at least 200ml of saline. Aside from lavage sessions, the lavage is paused, but continuous CSF drainage remains open.

Ventricular irrigation group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-65 years old;
  • CSF is purulent (it appears cloudy or yellow) and white blood cell count over 1000×10\^6/L.
  • Fever (\>38.0°C)
  • Meet at least one of the following: 1. Patient has organism(s) identified from CSF by a culture or non-culture based microbiologic testing method; 2. Cranial CT or MRI indicating intraventricular floccule or pus.
  • With consent form

You may not qualify if:

  • With GCS score of 3
  • With unstable vital signs such as no spontaneous breathing and blood pressure maintenance drugs
  • With severe propensity for bleeding (Such as coagulation dysfunction, active bleeding, etc.), and unable to tolerate the surgical procedures or operations related to ventricular irrigation treatment.
  • Pregnant or lactating women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (35)

The First Affiliated Hospital of University of Science and Technology of China

Hefei, Anhui, China

NOT YET RECRUITING

The Second People's Hospital of Anhui Province

Hefei, Anhui, China

NOT YET RECRUITING

The First Affiliated Hospital of Wannan Medical College

Wuhu, Anhui, China

NOT YET RECRUITING

Xuanwu Hospital Capital Medical University

Beijing, Beijing Municipality, China

NOT YET RECRUITING

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, China

NOT YET RECRUITING

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China

NOT YET RECRUITING

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, China

NOT YET RECRUITING

Shenzhen Second People's Hospital

Shenzhen, Guangdong, China

NOT YET RECRUITING

Zhongshan Hospital of Traditional Chinese Medicine

Zhongshan, Guangdong, China

NOT YET RECRUITING

The First Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

NOT YET RECRUITING

Henan Provincial People's Hospital

Zhengzhou, Henan, China

NOT YET RECRUITING

Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology

Wuhan, Hubei, China

RECRUITING

Xiangya Hospital of Central South University

Changsha, Hunan, China

NOT YET RECRUITING

Jiangsu Province Hospital

Nanjing, Jiangsu, China

NOT YET RECRUITING

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, China

NOT YET RECRUITING

Affiliated Hospital of Nantong University

Nantong, Jiangsu, China

NOT YET RECRUITING

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

NOT YET RECRUITING

904 Hospital of the People's Liberation Army Joint Logistic Support Force

Wuxi, Jiangsu, China

NOT YET RECRUITING

Affiliated Hospital of Yangzhou University

Yangzhou, Jiangsu, China

NOT YET RECRUITING

Ganzhou People's Hospital

Ganzhou, Jiangxi, China

NOT YET RECRUITING

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

NOT YET RECRUITING

The Fourth Affiliated Hospital of China Medical University

Shenyang, Liaoning, China

NOT YET RECRUITING

The Second Affiliated Hospital of Air Force Medical University

Xi'an, Shaanxi, China

NOT YET RECRUITING

Qilu Hospital of Shandong University

Jinan, Shandong, China

NOT YET RECRUITING

Renji Hospital, School of Medicine, Shanghai Jiaotong University

Shanghai, Shanghai Municipality, China

RECRUITING

Shanghai Donglei Brain Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

Shanghai East Hospital

Shanghai, Shanghai Municipality, China

NOT YET RECRUITING

Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, China

NOT YET RECRUITING

The Second Affiliated Hospital of Naval Medical University

Shanghai, Shanghai Municipality, China

NOT YET RECRUITING

West China Hospital, Sichuan University

Chengdu, Sichuan, China

NOT YET RECRUITING

Inner Mongolia People's Hospital

Hohhot, The Nei Monggol Autonomous Region, China

NOT YET RECRUITING

The First Affiliated Hospital of Xinjiang Medical University

Ürümqi, Xinjiang Uygur Autonomous Region, China

NOT YET RECRUITING

First Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, China

NOT YET RECRUITING

South taihu hospital affiliated to huzhou college

Huzhou, Zhejiang, China

RECRUITING

The affiliated people's hospital of ningbo university

Ningbo, Zhejiang, China

NOT YET RECRUITING

Related Publications (16)

  • Tunkel AR, Hasbun R, Bhimraj A, Byers K, Kaplan SL, Scheld WM, van de Beek D, Bleck TP, Garton HJL, Zunt JR. 2017 Infectious Diseases Society of America's Clinical Practice Guidelines for Healthcare-Associated Ventriculitis and Meningitis. Clin Infect Dis. 2017 Mar 15;64(6):e34-e65. doi: 10.1093/cid/ciw861.

    PMID: 28203777BACKGROUND

  • Al Menabbawy A, El Refaee E, Soliman MAR, Elborady MA, Katri MA, Fleck S, Schroeder HWS, Zohdi A. Outcome improvement in cerebral ventriculitis after ventricular irrigation: a prospective controlled study. J Neurosurg Pediatr. 2020 Sep 4;26(6):682-690. doi: 10.3171/2020.5.PEDS2063. Print 2020 Dec 1.

    PMID: 32886918BACKGROUND

  • Hasbun R. Healthcare-associated ventriculitis: current and emerging diagnostic and treatment strategies. Expert Rev Anti Infect Ther. 2021 Aug;19(8):993-999. doi: 10.1080/14787210.2021.1866544. Epub 2020 Dec 24.

    PMID: 33334204BACKGROUND

  • Humphreys H, Jenks PJ. Surveillance and management of ventriculitis following neurosurgery. J Hosp Infect. 2015 Apr;89(4):281-6. doi: 10.1016/j.jhin.2014.12.019. Epub 2015 Jan 29.

    PMID: 25687249BACKGROUND

  • Rogers T, Sok K, Erickson T, Aguilera E, Wootton SH, Murray KO, Hasbun R. Impact of Antibiotic Therapy in the Microbiological Yield of Healthcare-Associated Ventriculitis and Meningitis. Open Forum Infect Dis. 2019 Feb 6;6(3):ofz050. doi: 10.1093/ofid/ofz050. eCollection 2019 Mar.

    PMID: 30899767BACKGROUND

  • Karvouniaris M, Brotis A, Tsiakos K, Palli E, Koulenti D. Current Perspectives on the Diagnosis and Management of Healthcare-Associated Ventriculitis and Meningitis. Infect Drug Resist. 2022 Feb 28;15:697-721. doi: 10.2147/IDR.S326456. eCollection 2022.

    PMID: 35250284BACKGROUND

  • Karvouniaris M, Brotis AG, Tsiamalou P, Fountas KN. The Role of Intraventricular Antibiotics in the Treatment of Nosocomial Ventriculitis/Meningitis from Gram-Negative Pathogens: A Systematic Review and Meta-Analysis. World Neurosurg. 2018 Dec;120:e637-e650. doi: 10.1016/j.wneu.2018.08.138. Epub 2018 Aug 29.

    PMID: 30172065BACKGROUND

  • Luque-Paz D, Revest M, Eugene F, Boukthir S, Dejoies L, Tattevin P, Le Reste PJ. Ventriculitis: A Severe Complication of Central Nervous System Infections. Open Forum Infect Dis. 2021 Apr 29;8(6):ofab216. doi: 10.1093/ofid/ofab216. eCollection 2021 Jun.

    PMID: 34095339BACKGROUND

  • Chan AK, Birk HS, Yue JK, Winkler EA, McDermott MW. Bilateral External Ventricular Drain Placement and Intraventricular Irrigation Combined with Concomitant Serial Prone Patient Positioning: A Novel Treatment for Gravity-Dependent Layering in Bacterial Ventriculitis. Cureus. 2017 Apr 18;9(4):e1175. doi: 10.7759/cureus.1175.

    PMID: 28533993BACKGROUND

  • Terada Y, Mineharu Y, Arakawa Y, Funaki T, Tanji M, Miyamoto S. Effectiveness of neuroendoscopic ventricular irrigation for ventriculitis. Clin Neurol Neurosurg. 2016 Jul;146:147-51. doi: 10.1016/j.clineuro.2016.05.010. Epub 2016 May 9.

    PMID: 27219537BACKGROUND

  • Gaderer C, Schaumann A, Schulz M, Thomale UW. Neuroendoscopic lavage for the treatment of CSF infection with hydrocephalus in children. Childs Nerv Syst. 2018 Oct;34(10):1893-1903. doi: 10.1007/s00381-018-3894-7. Epub 2018 Jul 11.

    PMID: 29995267BACKGROUND

  • Qin G, Liang Y, Xu K, Xu P, Ye J, Tang X, Lan S. Neuroendoscopic lavage for ventriculitis: Case report and literature review. Neurochirurgie. 2020 Apr;66(2):127-132. doi: 10.1016/j.neuchi.2019.12.005. Epub 2020 Feb 19.

    PMID: 32087178BACKGROUND

  • Stati G, Migliorino E, Moneti M, Castioni CA, Scibilia A, Palandri G, Virgili G, Aspide R. Treatment of cerebral ventriculitis with a new self-irrigating catheter system: narrative review and case series. J Anesth Analg Crit Care. 2023 Nov 8;3(1):46. doi: 10.1186/s44158-023-00131-5.

    PMID: 37941074BACKGROUND

  • de Sousa Carvalho Dezena JE, Gerbelli CLB, Braga TKK, Ballestero MFM. How I do it: brainwashing for purulent ventriculitis. Acta Neurochir (Wien). 2023 Nov;165(11):3267-3269. doi: 10.1007/s00701-023-05607-5. Epub 2023 May 20.

    PMID: 37209145BACKGROUND

  • Tomita Y, Shimazu Y, Kawakami M, Matsumoto H, Fujii K, Kameda M, Yasuhara T, Suruga Y, Ota T, Kimata Y, Kurozumi K, Date I. Pyogenic Ventriculitis After Anterior Skull Base Surgery Treated With Endoscopic Ventricular Irrigation And Reconstruction Using a Vascularized Flap. Acta Med Okayama. 2021 Apr;75(2):243-248. doi: 10.18926/AMO/61908.

    PMID: 33953433BACKGROUND

  • Ochoa A, Arganaraz R, Mantese B. Neuroendoscopic lavage for the treatment of pyogenic ventriculitis in children: personal series and review of the literature. Childs Nerv Syst. 2022 Mar;38(3):597-604. doi: 10.1007/s00381-021-05413-3. Epub 2021 Nov 13.

    PMID: 34775525BACKGROUND

MeSH Terms

Conditions

Central Nervous System Infections

Condition Hierarchy (Ancestors)

InfectionsCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Jiyao Jiang, Dr

    Renji Hospital, School of Medicine, Shanghai Jiaotong University

    PRINCIPAL INVESTIGATOR

  • Junfeng Feng, Dr

    Renji Hospital, School of Medicine, Shanghai Jiaotong University

    STUDY DIRECTOR

  • Qinghua Wang, Dr

    Southern Medical University, China

    STUDY DIRECTOR

  • Xiaofeng Yang, Dr

    First Affiliated Hospital of Zhejiang University

    STUDY DIRECTOR

  • Yuhai Wang, Dr

    904th Hospital of the Joint Logistics Support Force of the PLA

    STUDY DIRECTOR

  • Xianjian Huang, Dr

    Shenzhen Second People's Hospital

    STUDY DIRECTOR

  • Xuefei Shao, Dr

    First Affiliated Hospital of Wannan Medical College

    STUDY DIRECTOR

  • Lijun Hou, Dr

    The Second Affiliated Hospital of Naval Medical University

    STUDY DIRECTOR

  • Chunlong Zhong, Dr

    Shanghai East Hospital

    STUDY DIRECTOR

  • Liang Gao, Dr

    Shanghai Donglei Brain Hospital

    STUDY DIRECTOR

  • Rongcai Jiang, Dr

    Xuanwu Hospital, Beijing

    STUDY DIRECTOR

  • Liansheng Long, Dr

    South Taihu Hospital Affiliated to Huzhou College

    STUDY DIRECTOR

  • Feng Gao, Dr

    he affiliated people's hospital of ningbo university

    STUDY DIRECTOR

  • Chunhua Hang, Dr

    The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

    STUDY DIRECTOR

  • Jing Ji, Dr

    The First Affiliated Hospital with Nanjing Medical University

    STUDY DIRECTOR

  • Xiaoou Sun, Dr

    The First Affiliated Hospital of Soochow University

    STUDY DIRECTOR

  • Aijun Peng, Dr

    Yangzhou University

    STUDY DIRECTOR

  • Jinlong Shi, Dr

    Affiliated Hospital of Nantong University

    STUDY DIRECTOR

  • Binghui Qiu, Dr

    Nanfang Hospital, Southern Medical University

    STUDY DIRECTOR

  • Dan Jin, Dr

    Zhongshan Hospital Of Traditional Chinese Medicine

    STUDY DIRECTOR

  • Yongxin Wang, Dr

    First Affiliated Hospital of Xinjiang Medical University

    STUDY DIRECTOR

  • Chaohua Yang, Dr

    West China Hospital

    STUDY DIRECTOR

  • Qibing Huang, Dr

    Qilu Hospital of Shandong University

    STUDY DIRECTOR

  • Yan Qu, Dr

    The Second Affiliated Hospital of Air Force Medical University

    STUDY DIRECTOR

  • Yan Zhang, Dr

    Second Affiliated Hospital of Nanchang University

    STUDY DIRECTOR

  • Qiuhua Jiang, Dr

    Ganzhou City People's Hospital

    STUDY DIRECTOR

  • Yijun Bao, Dr

    The Fourth Affiliated Hospital of China Medical University

    STUDY DIRECTOR

  • Hongsheng Liang, Dr

    First Affiliated Hospital of Harbin Medical University

    STUDY DIRECTOR

  • Wenhua Fang, Dr

    First Affiliated Hospital of Fujian Medical University

    STUDY DIRECTOR

  • Guang Feng, Dr

    Henan Provincial People's Hospital

    STUDY DIRECTOR

  • Kai Shu, Dr

    Tongji Hospital

    STUDY DIRECTOR

  • Jinfang Liu, Dr

    Xiangya Hospital of Central South University

    STUDY DIRECTOR

  • Weiping Zhao, Dr

    Inner Mongolia People's Hospital

    STUDY DIRECTOR

  • Yongming Zhang, Dr

    The Second People's Hospital of Anhui Province

    STUDY DIRECTOR

  • Xiangpin Wei, Dr

    The First Affiliated Hospital of University of Science and Technology of China

    STUDY DIRECTOR

  • Xianzhen Chen, Dr

    Shanghai 10th People's Hospital

    STUDY DIRECTOR

Central Study Contacts

Jiyao Jiang, Dr

CONTACT

021-68383729jiyaojiang@126.com

Junfeng Feng, Dr

CONTACT

13611860825fengjfmail@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2024

First Posted

April 10, 2024

Study Start

July 1, 2025

Primary Completion (Estimated)

June 30, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

February 25, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

Researchers who submit a methodologically sound study proposal that is approved by the management committee can have access to the study protocol, individual participant data and data dictionary. A Data Access Agreement is required, and all access must comply with regulatory restrictions imposed on the original study.

Shared Documents
STUDY PROTOCOL
Time Frame
After Publication
Access Criteria
Researchers who submit a methodologically sound study proposal that is approved by the management committee can have access to the study protocol, individual participant data and data dictionary.

Locations

CN(35)