A retrospective analysis of patients in real-world settings who received Rebyota for recurrent Clostridioides difficile infection (rCDI) found the treatment was safe and highly effective, researchers reported last week in Open Forum Infectious Diseases.

Rebyota is a fecal microbiota-based live (FMBL) therapeutic that was approved by the US Food and Drug Administration (FDA) for treatment of rCDI in December 2022, based on data from five prospective clinical trials. For the study, researchers retrospectively identified patients at five sites who had been deemed ineligible for trials because of comorbidities but were offered the drug through an FDA program that expands access to investigative drugs in settings that mimic real-world practice. The primary objective was to evaluate the safety and tolerability of FMBL through 6 months after treatment, and secondary objectives included evaluating efficacy after 8 weeks and sustained response after 6 months.

A total of 94 patients (mean age 59.8 years, 44.7% aged 65 years and older, 72.3% female) received treatment with FMBL from November 2015 through September 2019, with 64 in the primary safety set (PSS). Of the patients in the PSS, 70.3% had gastrointestinal and non-specific inflammation and dysfunctional conditions, and 65.6% had immune-mediated/autoimmune disorders. The vast majority (92%) of treatment-emergent adverse events (TEAEs) were mild to moderate in severity and comparable between comorbidity subgroups and the overall population.

In the PSS, 82.8% of Rebyota-treated patients responded at 8 weeks, of whom 88.7% had sustained response at 6 months. The rates of sustained clinical response were similar in patients who received one (90%) or two (87.9%) doses.

"Overall, this retrospective analysis is representative of real-world diagnostics and a patient population typically encountered in everyday practice," the study authors wrote. "The findings reinforce the potential efficacy and safety of FMBL in real-world populations with common rCDI comorbidities representative of clinical practice."

A pharmacist-led, post-discharge follow-up program for negative bacterial cultures at a community hospital showed the potential for significantly limiting unnecessary antibiotic exposure, researchers reported last week in the American Journal of Health-System Pharmacy.

The retrospective study, conducted by members of the pharmacy department at a 350-bed community hospital in Michigan that has had an established pharmacist-led culture follow-up program since 2015, reviewed bacterial cultures of adult patients treated and released from the hospital's emergency department (ED) or urgent care (UC) in August 2022. The aim was to characterize the proportion of patients with negative urine culture or chlamydia polymerase chain-reaction (PCR) test results and identify opportunities to de-prescribe antibiotics during follow-up telephone calls. While several studies have evaluated the impact of pharmacist-led follow up on antibiotic therapy with respect to positive cultures, there are no data regarding the impact when cultures are negative.

Of the 398 cultures reviewed, 208 (52%) had negative results, and 50 patients (24%) with negative results were prescribed empiric antibiotics on discharge. The median duration of antibiotic treatment was 7 days, while the median time to culture finalization was 2 days, resulting in an opportunity to save a median of 5 days of antibiotic exposure per patient and 236 total antibiotic days over the month.

Thirty-two patients (15.3%) followed up with their primary care physician within 7 days; of these patients, 1 (0.05%) had their antibiotic prescription discontinued by the primary care physician. There were no documented adverse drug reactions (ADRs).

Annualized, the intervention has the potential to save more than 2,800 days of unnecessary antibiotic therapy, the study authors noted.

"These findings represent a significant antimicrobial stewardship opportunity for pharmacists providing follow-up after ED and UC discharge to discontinue antimicrobial therapy, limiting unnecessary antimicrobial exposure, decreasing risk for development of resistance, and avoiding ADRs [adverse drug reactions]," they concluded.

Equatorial Guinea's health ministry on Mar 31 reported 1 more Marburg virus case, raising the outbreak total to 14.

In an update today, the ministry today said 10 people are hospitalized, including 2 of the confirmed patients and 8 who have suspected infections. Officials also reported one more death raising the total in the confirmed cases to 10.

Earlier in the outbreak, which began in January, the country reported 20 probable cases, all fatal. Currently, 604 people are under contact monitoring.

The cases have been reported across four districts, raising concerns about widespread activity. Eight of the cases have been reported from Bata, a port city with a population of about 173,000.

The US Centers for Disease Control and Prevention (CDC) recently issued a level 2 travel alert for Equatorial Guinea due to its Marburg virus, the country's first. The CDC urged people to avoid nonessential travel to affected provinces. The CDC has also issued a level 1 travel watch notice for Tanzania, another African country battling its first Marburg virus outbreak.

The US Centers for Disease Control and Prevention (CDC) recently announced a multistate Salmonella Infantis outbreak with a suspected link to flour, since most people reported eating raw dough or batter made with flour before they became ill.

Twelve cases have been reported, and illness onsets range from December 22, 2022, to February 13. Three people have been hospitalized, with no deaths reported. Patient ages range from 12 to 81, and 92% are female. The CDC said the number of sick people is probably much higher, because many people recover without needing medical care.

Of seven people interviewed about their food exposures before they got sick, six said they had eaten dough or batter. Flour was the only common ingredient, and health officials are doing trace-back investigations to see if there's a common brand.

Whole genome sequencing (WGS) suggests that the people infected in the outbreak got sick from eating the same kind of food. Also, WGS from 12 patient samples didn't predict resistance to any antibiotics.

Flour has been linked to foodborne illnesses before. The CDC repeated its warning that flour is considered a raw food and to avoid eating raw dough or batter.