July 23, 2021

Black fungus epidemic in India

By Dr. Volker Luibl, MBA, Cytiva

India’s COVID-19 pandemic is about to worsen, due to an outbreak of a fungal disease with a high death rate and a shortage of the appropriate treatment. We supported the Indian health system with syringe filters, water filters, and breathing filters.


The problem: contaminated water

India has recently seen an outbreak of infections of COVID-19 patients with mucormycosis, the so-called “black fungus”. Humans can contract the disease by breathing in fungal spores. It usually spreads in homes and hospitals via air humidifiers or oxygen tanks containing contaminated water.

The disease: Mucormycosis

Mucormycosis, colloquially known as black fungus, is an infection from the mucormycetes group of fungi. It is caused by exposure to mucormould which is commonly found in soil, plants, manure, and decaying fruits and vegetables. Black fungus first manifests as a skin infection in the air pockets behind the forehead, nose and cheekbone, and can spread to the lungs and brain. Symptoms include a bleeding nose, swollen and painful eyes and black patches of skin around the nose; a lung infection may result in fever, cough, or chest pain.

The normally rare infection already has a mortality rate of 20-50%; if treatment is delayed, this may rise to 94%.

People who do survive are often left permanently disfigured, as doctors may be forced to remove patients’ eyes and jaw bones to stop the infection from spreading to the brain. All of India’s 29 states have declared the disease an epidemic.

The link to coronavirus: the compromised immune system

Thousands of these cases in India affect recovered and recovering COVID-19 patients. This is thought to be linked to steroids used indiscriminately in the treatment of COVID-19 patients (steroids suppress the immune system and therefore make it easier for an infection to take hold).

But the second and probably main reason is the prolonged unhygienic oxygen delivery to patients: medical oxygen (MO) needs to be prepared in several steps of compressions, filtration and purification, while the cylinders storing the (liquid) oxygen must be rigorously and regularly cleaned and disinfected. To humidify the oxygen, it is passed through a container with sterile water – if this water is contaminated with fungal spores, then the oxygen meant for very ill patients will contain them too.

The treatment: amphotericin B

The key drug is amphotericin B, a potent antifungal drug that is used solely to treat potentially life-threatening fungal infections in patients with a normal immune system. The stark increase in black fungus cases has led to a shortage of amphotericin B, a drug with a lengthy production cycle of up to 28 days. As existing manufacturers ramp up their production, the Drugs Controller General of India (DCGI) has already cleared applications from five further pharmaceutical companies to manufacture the life-saving drug.

Managing the black fungus epidemic in India: Pall Medical filters

To support the Indian health system, we offer syringe filters, point-of-use water filters, medical gas filters and breathing filters.

1. Our syringe filter

Amphotericin B, an antifungal drug and the number one choice for treating patients with black fungus, is infused intravenously and requires filtration (1).

Drug
Pore-size recommendation
for the preparation of the drug
Pore-size recommendation
for the administration of the drug
Amphotericin B lipid Complex (Abelcet)
5 μm
x
Amphotericin B liposomal (Abelcet)
5 μm
≥ 1 μm for administration (optional)
  • Our solution for pharmaceutical companies: Gardian™
    We offer required filter for pharmaceutical companies to bundle our filters with the drug (within a drug product box).
  • Our solution for pharmacists and clinicians: Pharmassure™
    We offer required filter for pharmacists and clinicians direct and without the drug.

2. Our gas and breathing filters

Our breathing system filters have been validated for the retention of bacteria and viruses (including the SARS-CoV-2 virus – please note this claim has been cleared for Europe under CE-Mark only) and will protect ventilated patients from airborne contaminants derived from the ventilator and gas supply equipment. Medical gas filters (e.g., ORO1H) have been developed to retain microbiological contamination from oxygen and can be used on the gas outlet of oxygen concentrators.

In addition to our registered products a variety of gas filters and gas filtration media is available for OEM customers to be included in respective equipment.

3. Our point-of-use water filters 

Pall-Aquasafe™ disposable water filters and QPoint™ filter capsules and water filters are designed and validated to remove bacteria, protozoa, fungi and particles from the water supply.

The incorporated double layer sterilizing grade 0.2 μm Supor™ membrane has been shown to completely retain Brevundimonas diminuta, when tested by industry standard laboratory liquid microbial challenge tests used for validating 0.2 μm sterilizing grade filters to ≥ 107 colony forming units (cfu)/cm2 of effective filtration area. In addition, our point of-use water filters have shown to efficiently retain Aspergillus fumigatus, following simulated intermittent use for 31 days, to ≥ 107 cfu/cm2 for Pall-Aquasafe water filters and for 62 days, to ≥ 107 cfu/cm2 for QPoint filter capsules and filters.

Mucormycetes, the agents responsible of black fungus infections, are ubiquitous fungi and they include a group of filamentous fungi in the subphylum Mucormycotina with spores ranging from 3 to 11 µm in diameter. Hence, the spores are larger than bacteria such as B. diminuta and fungi such as A. fumigatus. Based on size, it is expected that our point-of-use water filters will effectively retain mucormycetes.

References

  1. Ipema HJ, Zacher JM, Galka E, Nasari J, Varabyeva A, Yu M, et al. Drugs to Be Used With a Filter for Preparation and/or Administration-2019. Hosp Pharm. 2021;56(2):81-87. doi:10.1177/0018578719867660.

Author bio

Dr. Volker Luibl, MBA

Dr. Volker Luibl, MBA

Dr. Luibl is Demand Generation Marketing Manager in medical device and clinical science.