A Phase 4 interventional study of Azithromycin plus piperaquine phosphate and Sulfadoxine-pyrimethamine in Pregnancy, Infections, Plasmodia and Drug Kinetics, sponsored by Papua New Guinea Institute of Medical Research. Status unknown at 1 site in Papua New Guinea. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-10-15.
Sponsored by Papua New Guinea Institute of Medical Research · Phase 4, Interventional, and Prevention
Plasmodium falciparum parasitaemia in pregnancy is associated with maternal anaemia, low birth-weight and increased perinatal mortality. Whilst continuous prophylaxis is difficult to implement, intermittent presumptive treatment in pregnancy (IPTp) has proved to be practical and effective. In PNG, pregnant women currently receive IPTp using sulfadoxine-pyrimethamine, however, this therapy has the potential to be compromised by parasite resistance.
The aim of the present trial is to assess the safety, tolerability, pharmacokinetics and efficacy of azithromycin (AZI) plus piperaquine (PQ) given as IPTp to pregnant Papua New Guinea women. The study will comprise of two sub-studies:
(i) A safety, tolerability and pharmacokinetic study of AZI-PQ in pregnancy. (ii) A safety, tolerability and preliminary efficacy study of AZI-PQ in pregnancy.
1,299 studies on the registry are indexed under Malaria; 86 are open to participants now.
This study's planned enrollment of 150 is below the median of 220 across 1,027 interventional studies indexed under Malaria.
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At baseline, participants receive three daily doses (0, 24 and 48 hours) of i) 1 g azithromycin as 2 x film-coated 500 mg tablets ii) 960 mg piperaquine tetraphosphate tablets as 3 x 320 mg tablets
Drug: Azithromycin plus piperaquine phosphate
At baseline, participants receive a single dose of sulfadoxine-pyrimethamine comprising 1,500 mg of sulfadoxine and 75 mg pyrimethamine in tablet form
Drug: Sulfadoxine-pyrimethamine
At baseline, participants receive three daily doses (0, 24 and 48 hours) of i) 1 g azithromycin as 2 x film-coated 500 mg tablets ii) 960 mg piperaquine tetraphosphate tablets as 3 x 320 mg tablets
Drug: Azithromycin plus piperaquine phosphate
Also known as: Sandoz Azithromycin, Sigma-Tau Piperaquine tetraphosphate
Efficacy of azithromycin plus piperaquine for the prevention of malaria during pregnancy
The efficacy of azithromycin plus piperaquine for the prevention of malaria infection during pregnancy will be investigated in 120 women. Women will be randomized to receive either (i) 3 daily doses of AZI plus PQ, or, (ii) single dose sulfadoxine-pyrimethamine Participants will be actively followed for a period of 42 days (1, 2, 3, 4, 7, 14, 21, 28 and 42 days after treatment). At each follow-up time point the participant will have a clinical examination, fundal height measurement and assessment of foetal lie, perform a symptoms questionnaire, blood film for malaria and other scheduled safety tests (eg. Hb, glucose, ultrasound). A single blood sample for pharmacokinetic analysis will be collected at Day 4. At delivery all participants and their babies will be assessed, including blood sample for Hb, glucose, blood spot for PCR, cord blood and maternal blood. Breast milk samples will be collected for 2 weeks (Day 1, 2, 3, 4, 7, 14) after the establishment of lactation.
Time frame: 42 days intensive follow-up, final end-point at 2 weeks post delivery
Pharmacokinetics - distribution, terminal elimination and absorption half-life(t1/2) of azithromycin and piperaquine
Time frame: 42 days intensive follow-up, final end-point at 2 weeks post delivery
Pharmacokinetics - area under the plasma concentration versus time curve (AUC) of azithromycin and piperaquine
Time frame: 42 days intensive follow-up, final end-point at 2 weeks post delivery
Pharmacokinetics - peak plasma concentration (Cmax) of azithromycin and piperaquine
Time frame: 42 days intensive follow-up, final end-point at 2 weeks post delivery
Pharmacokinetics - clearance (CL) of azithromycin and piperaquine
Time frame: 42 days intensive follow-up, final end-point at 2 weeks post delivery
Pharmacokinetics - volume of distribution (Vd) of azithromycin and piperaquine
Time frame: 42 days intensive follow-up, final end-point at 2 weeks post delivery
PCR adjusted 28 day cure
Time frame: 28 days
PCR adjusted 42 day cure
Time frame: 42 days
Number of participants with adverse events as a measure of safety and tolerability
Time frame: 42 days intensive follow-up, final end-point at 2 weeks post delivery
Change in maternal hemoglobin over 28 days
Time frame: 28 days
Change in maternal weight over 28 days
Time frame: 28 days
Infant birth weight
Time frame: Time of delivery
Maternal parasitaemia
Time frame: Time of delivery
Placental parasitaemia
Time frame: Time of delivery
Cord blood parasitaemia
Time frame: Time of delivery
Maternal hemoglobin at delivery
Time frame: Time of delivery
This study is status unknown, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.
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Papua New Guinea Institute of Medical Research