Evaluation of the effectiveness of intrathecal versus intraventricular antimicrobial therapy for bacterial meningitis following craniotomy: a clinical trial

Comparing the effectiveness of intravenous and intraventricular antimicrobial therapy for bacterial meningitis following craniotomy

A controlled, parallel-group, single-blind, randomized, simple random assignment clinical trial, phase 3, on 30 patients.

The present study will be conducted in the ICU of Golestan Hospital, Ahvaz. The study population is patients with meningitis caused by gram-negative bacteria after craniotomy and EVD infection simultaneously or during hospitalization according to CDC criteria. Blinding in the present study will be performed at the level of participant, data analyst, and outcome assessor.

Inclusion criteria: Patients aged 16-80 years with meningitis caused by gram-negative bacteria after craniotomy and EVD insertion simultaneously or during hospitalization, patient consent. Exclusion criteria: History of shunt placement, previous brain or spinal surgery, recent antibiotic intake, sensitivity to study drugs, renal dysfunction, and death during the study.

intravenous treatment including, 2 grams of meropenem (2 g/kg/day) every 8 hours if the culture result is gram-negative, and 1 gram of vancomycin (1 g/kg/day) every 12 hours if the culture result is gram-positive, along with intracranial treatment: 125 units of colistin daily (125 IU q24h) and 80 grams of vancomycin daily (80 g/kg/day) if the culture result is gram-positive. The control group: intravenous treatment including, 2 grams of meropenem (2 g/kg/day) every 8 hours if the culture result is gram-negative, and 1 gram of vancomycin (1 g/kg/day) every 12 hours if the culture result is gram-positive

14-day mortality, length of stay in ICU, positive blood culture, need for tracheostomy, duration of positive CSF culture and biochemistry smear results

In this study, simple randomization will be used to allocate patients to two parallel groups (intrathecal versus intraventricular therapy) with a 1:1 allocation ratio. The randomization unit is the individual patient. Random allocation will be performed using a computer-generated random number table to ensure that each participant has an equal probability of being assigned to either study arm. To implement this, sequentially numbered, opaque, sealed envelopes (SNOSE) containing the group assignments (odd numbers for the intrathecal group and even numbers for the intraventricular group) will be prepared. Upon enrollment and after obtaining informed consent, the coordinator will open the corresponding envelope in sequence. The allocation sequence will be concealed from both the principal investigators and the outcome assessors. Potential confounding factors, including the presence of an external ventricular drain (EVD), primary indication for craniotomy, age, gender, and underlying comorbidities, will be controlled during the data analysis stage using stratification or multivariate regression models.

Due to the nature of the intervention, blinding of participants and healthcare providers (physicians and nurses involved in delivering the intervention) is not feasible; therefore, they will be aware of group allocation. However, blinding will be implemented at the level of outcome assessment and data analysis. Outcome assessors responsible for data collection and outcome recording will be blinded to group allocation and will only identify participants using coded labels (A and B). In addition, the statistician performing data analysis will be blinded to treatment allocation, and all analyses will be conducted using anonymized and coded datasets without access to intervention-related information.

There is no more information.

The raw data file will not be made available to other researchers. The results of the data analysis will be published in the form of an article only after the study is completed.

The raw data file will not be made available to other researchers.

There is no more information.

There is no more information.

Dr. Armin Jahangiri babadi, armin57.jb@gmail.com

It is available after correspondence with Dr. Armin Jahangiri Babadi. It is important to note that only the editor of the journal to which the article will be submitted will be allowed to request access to the data to prove the reliability and trustworthiness of the results. After going through these steps, access will be available approximately 1 week later.