Trial Outcomes & Findings for Comparison of Two Different Doses of Azithromycin for Treatment of Yaws (NCT NCT02344628)

NCT ID: NCT02344628

Last Updated: 2018-10-31

Results Overview

Clinical resolution of skin lesion at 4 weeks and at least four-fold decline in Rapid Plasma Reagin titre or seroreversion at 6-month (compared to baseline) in T.pallidum subsp. pertenue Polymerase Chain Reaction-confirmed subjects with yaws.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 583 participants
• Primary outcome timeframe: 6 Months
• Results posted on: 2018-10-31

Participant Flow

Participant milestones

Measure	AZT30 Single dose of azithromycin at a dose of 30mg/kg - max 2 Grams Azithromycin: Comparison of two different dosing strategies for the treatment of yaws	AZT20 Single dose of azithromycin at a dose of 20mg/kg - max 1 Grams Azithromycin: Comparison of two different dosing strategies for the treatment of yaws
Overall Study STARTED	291	292
Overall Study COMPLETED	200	206
Overall Study NOT COMPLETED	91	86

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparison of Two Different Doses of Azithromycin for Treatment of Yaws

Baseline characteristics by cohort

Measure	AZT30 n=291 Participants Single dose of azithromycin at a dose of 30mg/kg - max 2 Grams Azithromycin: Comparison of two different dosing strategies for the treatment of yaws	AZT20 n=292 Participants Single dose of azithromycin at a dose of 20mg/kg - max 1 Grams Azithromycin: Comparison of two different dosing strategies for the treatment of yaws	Total n=583 Participants Total of all reporting groups
Age, Continuous	10 years n=113 Participants	10 years n=163 Participants	10 years n=160 Participants
Sex: Female, Male Female	83 Participants n=113 Participants	88 Participants n=163 Participants	171 Participants n=160 Participants
Sex: Female, Male Male	208 Participants n=113 Participants	204 Participants n=163 Participants	412 Participants n=160 Participants
Region of Enrollment Papua New Guinea	92 participants n=113 Participants	91 participants n=163 Participants	183 participants n=160 Participants
Region of Enrollment Ghana	199 participants n=113 Participants	201 participants n=163 Participants	400 participants n=160 Participants

PRIMARY outcome

Timeframe: 6 Months

Clinical resolution of skin lesion at 4 weeks and at least four-fold decline in Rapid Plasma Reagin titre or seroreversion at 6-month (compared to baseline) in T.pallidum subsp. pertenue Polymerase Chain Reaction-confirmed subjects with yaws.

Outcome measures

Measure	AZT30 n=81 Participants Single dose of azithromycin at a dose of 30mg/kg - max 2 Grams Azithromycin: Comparison of two different dosing strategies for the treatment of yaws	AZT20 n=76 Participants Single dose of azithromycin at a dose of 20mg/kg - max 1 Grams Azithromycin: Comparison of two different dosing strategies for the treatment of yaws
Number of Participants With Clinical and Serological Cure	68 Participants	61 Participants

SECONDARY outcome

Timeframe: 6 Months

Clinical resolution of skin lesion at 4 weeks and at least four-fold decline in Rapid Plasma Reagin titre or seroreversion at 6-month (compared to baseline) in T.pallidum subsp. pertenue Polymerase Chain Reaction-negative.

Outcome measures

Measure	AZT30 n=125 Participants Single dose of azithromycin at a dose of 30mg/kg - max 2 Grams Azithromycin: Comparison of two different dosing strategies for the treatment of yaws	AZT20 n=124 Participants Single dose of azithromycin at a dose of 20mg/kg - max 1 Grams Azithromycin: Comparison of two different dosing strategies for the treatment of yaws
Number of Participants With Clinical and Serological Cure in Latent Yaws	65 Participants	73 Participants

SECONDARY outcome

Timeframe: 6 months

To compare the incidences and relative risk of all Adverse Events (AEs), including treatment-related AEs, Serious Adverse Events (SAEs) and grade 3-4 toxicity in patients treated with AZT20 and AZT30 regimens

Outcome measures

Measure	AZT30 n=291 Participants Single dose of azithromycin at a dose of 30mg/kg - max 2 Grams Azithromycin: Comparison of two different dosing strategies for the treatment of yaws	AZT20 n=292 Participants Single dose of azithromycin at a dose of 20mg/kg - max 1 Grams Azithromycin: Comparison of two different dosing strategies for the treatment of yaws
Number of Participants With Adverse Events	12 Participants	14 Participants

Adverse Events

AZT30

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

AZT20

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	AZT30 n=291 participants at risk Single dose of azithromycin at a dose of 30mg/kg - max 2 Grams Azithromycin: Comparison of two different dosing strategies for the treatment of yaws	AZT20 n=292 participants at risk Single dose of azithromycin at a dose of 20mg/kg - max 1 Grams Azithromycin: Comparison of two different dosing strategies for the treatment of yaws
Gastrointestinal disorders Abdominal Discomfort	1.0% 3/291	2.1% 6/292
Gastrointestinal disorders Diarrhoea	0.69% 2/291	0.68% 2/292
Nervous system disorders Dizziness	0.69% 2/291	1.4% 4/292
Nervous system disorders Headache	0.69% 2/291	0.00% 0/292
Skin and subcutaneous tissue disorders Itching	0.00% 0/291	0.68% 2/292
Gastrointestinal disorders Nausea	1.4% 4/291	0.00% 0/292
Skin and subcutaneous tissue disorders Rash	0.00% 0/291	0.34% 1/292

Additional Information

Dr Michael Marks

London School of Hygiene and Tropical Medicine

Phone: +447984643424

Email: michael.marks@lshtm.ac.uk

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place