Gallium nitrate for Nontuberculous Mycobacterial Infections

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Nontuberculous Mycobacterial InfectionsGallium nitrate - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test the safety of two 5-day cycles of gallium given intravenously to adults with CF who also have an infection with NTM.

Eligible Conditions
  • Nontuberculous Mycobacterial Infections

Treatment Effectiveness

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: Day 6 to Day 111

Baseline to Day 57
Adverse Events of Special Interest
Clinically significant abnormal laboratory measures. (safety)
Day 111
NTM clearance (efficacy)

Trial Safety

Side Effects for

Gallium
48%Cough
32%Sputum increased
32%Fatigue
28%Headache
20%Chest discomfort
15%Nausea
15%Sinus congestion
13%Decreased appetite
13%Oropharyngeal pain
13%Dyspnoea
12%Pyrexia
12%Haemoptysis
10%Asthenia
10%Myalgia
10%Abdominal pain
8%Chest pain
8%Nasal congestion
8%Wheezing
7%Rhinorrhoea
7%Vomiting
7%Muscle spasms
7%Pulmonary congestion
7%Diarrhoea
7%Pain in extremity
7%Weight decreased
7%Rash
7%Paranasal sinus hypersecretion
5%Pulmonary function test decreased
3%Constipation
3%Sinus headache
3%Contusion
2%Distal intestinal obstruction syndrome
2%Arthralgia
2%Abdominal pain upper
2%Seizure
2%Night sweats
2%Forced expiratory volume decreased
2%Exercise tolerance decreased
2%Dyspnoea exertional
2%Upper-airway cough syndrome
2%Rales
This histogram enumerates side effects from a completed 2018 Phase 2 trial (NCT02354859) in the Gallium ARM group. Side effects include: Cough with 48%, Sputum increased with 32%, Fatigue with 32%, Headache with 28%, Chest discomfort with 20%.

Trial Design

1 Treatment Group

Infusion of IV Gallium
1 of 1

Experimental Treatment

40 Total Participants · 1 Treatment Group

Primary Treatment: Gallium nitrate · No Placebo Group · Phase 1

Infusion of IV Gallium
Drug
Experimental Group · 1 Intervention: Gallium nitrate · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gallium nitrate
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: day 6 to day 111

Who is running the clinical trial?

Chris GossLead Sponsor
4 Previous Clinical Trials
2,229 Total Patients Enrolled
Cystic Fibrosis FoundationOTHER
174 Previous Clinical Trials
34,800 Total Patients Enrolled
Christopher H. Goss, MD, MScPrincipal InvestigatorUniversity of Washington, Seattle Children's Hospital

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
The person must be 18 years or older at the time of the first visit.
is an important predictor of mucus hypersecretion and poor outcomes in cystic fibrosis (CF) CF patients with a sweat chloride concentration of more than 60 milliequivalents per liter are more likely to experience mucus hypersecretion and have poorer outcomes.
The person responsible for obtaining written informed consent from a subject or the subject's legal representative is known as the consenting authority.
I will follow the study schedule and other requirements to the best of my ability.
, p.Phe508del and ΔF508, account for the vast majority of CFTR-associated cystic fibrosis (CF) cases
Two positive NTM culture results from sputum (or BAL) at least 28 days apart.
You have both a positive culture result for M
You have no cultures positive for NTM since the first of the two qualifying positive culture results.