Clinical Research Directory

Curcumin Extract Added to Ciprofloxacin for Typhoid Carriers Among Food Handlers of the Free Nutritious Meal Program

Some people keep carrying Salmonella Typhi after they recover from typhoid fever. These carriers have no symptoms. They can still pass the bacteria into food. Food handlers in the Free Nutritious Meal Program (Makan Bergizi Gratis, MBG) cook for many school children every day. One carrier in an MBG kitchen can cause an outbreak. Standard antibiotics often fail to clear the carrier state. The bacteria form a biofilm on gallstones. This biofilm protects them from antibiotics. Curcumin is the main active compound of turmeric. In laboratory studies, curcumin weakens the biofilm. It may also help ciprofloxacin stay longer inside the bacteria. This study has two stages. In stage 1, the study team screens 100 MBG food handlers in Surakarta, Indonesia. Each person gives a blood sample for the Widal test. People with a high Widal titer give a rectal swab for culture. In stage 2, people with a positive Salmonella Typhi culture are randomly assigned to one of two groups. One group takes ciprofloxacin plus curcumin extract. The other group takes ciprofloxacin plus placebo. Treatment lasts 28 days. The main question is whether curcumin added to ciprofloxacin clears Salmonella Typhi better than ciprofloxacin alone. The main outcome is a negative rectal swab culture 30 days after treatment ends.

COMPARISON OF SINGLE VERSUS COMBINATION DRUG THERAPY IN EXTENSIVELY DRUG RESISTANT SALMONELLA TYPHI IN TERMS OF TIME TO DEFERVESCENCE

This randomized controlled trial will compare the effectiveness of single-drug therapy (meropenem) versus combination therapy (meropenem plus azithromycin) in children aged 2-16 years diagnosed with extensively drug-resistant (XDR) typhoid fever at the Children's Hospital, Lahore. A total of 94 patients will be enrolled and randomly assigned to either treatment group. The primary outcome is time to defervescence, defined as sustained resolution of fever for more than 48 hours. Secondary outcomes include duration of hospital stay and complication rates. The study aims to provide evidence to guide optimal management of XDR typhoid in pediatric populations."

Induction of Gut Permeability by an Oral Vaccine

This study evaluates the effect of an oral typhoid vaccine on disruption of the intestinal barrier and response of the immune system. Intestinal and whole-body responses will be measured in all participants before and after the vaccine.

ZyVac-TCV Bangladesh Study

This is a prospective closed cohort, open-label, phase III effectiveness study using a test-negative design of a typhoid conjugate vaccine, ZyVac® TCV (purified Vi capsular polysaccharide of Salmonella Typhi conjugated to tetanus toxoid as carrier protein), manufactured by Zydus Lifesciences Limited. The study will be conducted in a closed cohort population among children aged 6 months to 15 years residing in wards 5, 6, 7, 48, 49, 50, 63, 71, and 72 of Dhaka South City Corporation (DSCC). The targeted number of age-eligible children in the study area is \~92,000 among them \~60,000 will be vaccinated. A subset of the first 600 consenting participants will be selected by age strata (6 months to \<2 years, 2-4 years, 5-15 years) for enrollment in the immunogenicity study with an additional three follow-up visits. Diary cards will be used to collect adverse events (AEs) following immunization (AEFI) data up to day 7 for a subset of active follow-up of the first 600 vaccinated participants. Participants not in this subset will be encouraged to go to the 'Adverse Event Monitoring Cell' at the Maniknagar field office. Data on serious adverse events (SAEs) will be reported for six months after vaccination. All study updates including AEs and SAEs will be reported to the data safety and monitoring board (DSMB) and sponsor. Passive surveillance for typhoid fever will be carried out in the Maniknagar field office and Mugda Medical College and Hospital in the catchment area among the age-eligible children.