No Correlation Found in Association Between Malignancies and C Difficile Infections

Chetana Vaishnavi, PhD

New research did not show a statistically significant association between different malignant disorders and clostridium difficile infections (CDI).

A team, led by Chetana Vaishnavi, PhD, Postgraduate Institute Of Medical Education And Research, quantified the link between C difficile infections in patients with different kinds of malignancies.

While there are several diseases that are known risk factors for C difficile infections, there is little known about the association between malignancy and CDI.

The Study

In the study, the investigators identified 496 patients with specific malignancies, including adenocarcinoma, hematological malignancies, multiple myeloma, and pediatric solid tumor. The patients were compared to 526 control group participants.

The investigators reviewed laboratory data on demographics, antibiotic exposure, clinical symptoms, and fecal Clostridioides difficile toxin assay for all 1022 participants.

In addition, 805 patients received antibiotics.

The Data

Clostridioides difficile toxin was positive for 28% (n = 7) of patients with pediatric solid tumor, 25% (n = 24) of patients with adenocarcinoma, 21.4% (n = 71) of patients with hematological malignancies, and 7% (n = 3) of patients with multiple myeloma.

However, this was not significant (P >0.05).

The investigators did find a correlation between different malignant conditions and different demographics. For example, males with adenocarcinoma (P = 0.039) and hematological malignancies (P = 0.003), antibiotic exposure in multiple myeloma (P <0.001) and fever in pediatric solid tumor and hematological malignancies subgroups were deemed significant (P <0.001).

“No significant association of [Clostridioides difficile toxin] was seen in malignant patients compared to the controls, though patients in [pediatric solid tumors] and [adenocarcinoma] subgroups were more prone to CDI,” the authors wrote.

A Potential Treatment

Earlier this year, investigators found a new orally administered adsorbent could prevent antibiotic disruption of intestinal flora against C difficile in patients with hematologic malignancies.

An investigational formulation of an adsorbent to protect against antibiotic disruption of intestinal microbiota and colonization of C diff will be evaluated in a phase 3 clinical trial in patients with hematologic malignancies who require antibiotics for severe infections while receiving intensive chemotherapy.

DAV132 is an orally administered formulation that releases 5gm of activated charcoal from a 7.5 gm dosage into, or after passage through the ileum.

In results from a phase 2 trial described by the manufacturer, 7.5gm of DAV132 administered 3 times daily to elderly patients receiving oral or intravenous fluoroquinolone antibiotics demonstrated protection against antibiotic-induced disruption of intestinal microbiota.

According to the manufacturer's summary of the trial results, the adsorbent product significantly reduced free fecal concentrations of fluoroquinolones without affecting their plasma levels, and therefore without affecting their efficacy in treating the patients' infections.

The delayed release of the activated charcoal ingredient was also found in a phase 1 study to avoid the potential interaction with concurrently administered drugs. That study was conducted with healthy volunteers receiving a 7.5gm dose of DAV132 concurrently with either 5mg of the anticoagulant warfarin, or 1mg of the antiepileptic clonazepam.

The study, "Association of Clostridioides difficile infection with specific malignant conditions," was published online in the Journal of Microbiology and Infectious Diseases.